Diabetic Neuropathy, Painful
Conditions
Brief summary
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.
Interventions
DRUGduloxetine hydrochloride
Duloxetine (DLX) once daily (QD), orally (PO)
DRUGpregabalin
Pregabalin (PGB) orally (PO)
DRUGgabapentin
Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* You must have been diagnosed with Diabetic Neuropathic Pain * Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted * Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report * Patient must agree not to change dose of gabapentin between Visits 1 and 2 * You must have stable glycemic control
Exclusion criteria
* Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II) * Current diagnosis or history of hemangiosarcoma * Patients with New York Heart Association Class III or IV symptoms of congestive heart failure * Patients with uncontrolled narrow-angle glaucoma * Presence of a current seizure disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine | baseline, 12 weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin | baseline, 12 weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score | baseline, 12 weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | baseline, 12 weeks | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks | 12 weeks | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | baseline, 12 weeks | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | baseline, 12 Weeks | A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | baseline, 12 weeks | A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | baseline, 12 weeks | A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | baseline, 12 weeks | A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | baseline, 12 weeks | The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks | baseline, 12 weeks | This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. |
| Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score | baseline, 12 weeks | This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. |
| Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks | baseline, 12 weeks | This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. |
| Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | baseline, 12 weeks | The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | baseline, 12 weeks | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | baseline through 12 weeks | — |
| Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | baseline, 12 weeks | 14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site. |
| Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | baseline, 12 weeks | 14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score. |
| Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | baseline, 12 weeks | The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | baseline, 12 weeks | The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score. |
| Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms | baseline through 12 weeks | Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects. |
| Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score | baseline, 12 weeks | A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | baseline, 12 weeks | The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care. |
| Summary of Number of Participants Who Discontinued | baseline through 12 weeks | Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow. |
| Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score | baseline through 12 weeks | This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. |
| Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score | baseline through 12 weeks | This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20. |
| Number of Participants With Treatment-emergent Elevated Blood Pressure | baseline through 12 weeks | Elevated systolic blood pressure: \>=130 millimeter mercury (mm Hg) + an increase of \>=10 mm Hg if baseline \<130 mm Hg. Elevated diastolic blood pressure: \>=85 mm Hg + an increase of \>=10 mm Hg if baseline \<85 mm Hg. |
| Number of Participants With Treatment-Emergent Elevated Heart Rate | baseline through 12 weeks | Elevated heart rate: \>=100 beats per minute (bpm) + an increase of \>=10 bpm if baseline \<100 bpm. |
| Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score | baseline through 12 weeks | This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group. |
| Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score | baseline through 12 weeks | This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. |
| Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD) | baseline, 12 weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. It was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible. |
| Number of Participants With Treatment-Emergent Changes in Body Weight | baseline through 12 weeks | Treatment-emergent high body weight: weight at last visit \>=107% of baseline weight. Treatment-emergent low body weight: weight at last visit \<=93% of baseline weight. |
| Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | baseline, 12 weeks | Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site. |
| Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for \<56 contiguous days prior to randomization. Prior use: use of gabapentin for \>=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | baseline through 12 weeks | Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs. |
| Mean Change From Baseline to 12 Weeks in Blood Pressure | baseline through 12 weeks | Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Heart Rate | baseline through 12 weeks | Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity | baseline, 12 weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. |
| Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, 12 weeks | Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos |
| Mean Change From Baseline to 12 Weeks in Total Bilirubin | baseline, 12 weeks | — |
| Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | baseline, 12 weeks | — |
| Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | baseline, 12 weeks | — |
| Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | baseline through 12 weeks | Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): \>34, male (m): \>36. Alanine Aminotransferase (ALT): f:\<69 years (yr) \>34, ≥69yr \>32; m: \<69yr \>43, ≥69yr \>35. Total Bilirubin (TBili): \>21. Gamma Glutamyl Transferase (GGT): f: \<59yr \>49, ≥59yr \>50; m: \<59yr \>61, ≥59yr \>50. Fasting Plasma Glucose (FPG): \<59yr \>6.4, ≥59yr \>6.7. Hemoglobin A1C (HbA1C) \>6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr \>106, 50-70yr \>123, 70-80yr \>164, ≥80yr \>221; m: 18-50yr \>129, 50-70yr \>131, 70-80yr \>156, ≥80yr \>187 |
| Mean Change From Baseline to 12 Weeks in Body Weight | baseline through 12 weeks | Least-squares means represent adjustment due to baseline severity and investigative site. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks. | 134 |
| Duloxetine Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks. | 138 |
| Gabapentin + Duloxetine Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks. | 135 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 27 | 18 |
| Overall Study | Lack of Efficacy | 5 | 9 | 5 |
| Overall Study | Lost to Follow-up | 6 | 6 | 5 |
| Overall Study | Physician Decision | 2 | 1 | 2 |
| Overall Study | Protocol Violation | 5 | 2 | 1 |
| Overall Study | Sponsor Decision | 2 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Duloxetine | Total | Pregabalin | Gabapentin + Duloxetine |
|---|---|---|---|---|
| Age Continuous | 60.94 years STANDARD_DEVIATION 10.18 | 61.56 years STANDARD_DEVIATION 10.56 | 61.89 years STANDARD_DEVIATION 10.7 | 61.85 years STANDARD_DEVIATION 10.84 |
| Beck Depression Inventory (BDI) Total Score | 9.10 units on a scale STANDARD_DEVIATION 7.2 | 9.74 units on a scale STANDARD_DEVIATION 8.07 | 9.45 units on a scale STANDARD_DEVIATION 8.53 | 10.71 units on a scale STANDARD_DEVIATION 8.42 |
| Clayton Sexual Functioning Questionnaire (CSFQ) female participants - arousal | 7.00 units on a scale STANDARD_DEVIATION 2.72 | 6.70 units on a scale STANDARD_DEVIATION 3.01 | 6.64 units on a scale STANDARD_DEVIATION 3.2 | 6.47 units on a scale STANDARD_DEVIATION 3.09 |
| Clayton Sexual Functioning Questionnaire (CSFQ) female participants - desire/frequency | 4.27 units on a scale STANDARD_DEVIATION 1.83 | 3.93 units on a scale STANDARD_DEVIATION 1.77 | 3.79 units on a scale STANDARD_DEVIATION 1.85 | 3.74 units on a scale STANDARD_DEVIATION 1.59 |
| Clayton Sexual Functioning Questionnaire (CSFQ) female participants - desire/interest | 5.97 units on a scale STANDARD_DEVIATION 2.42 | 5.89 units on a scale STANDARD_DEVIATION 2.63 | 5.96 units on a scale STANDARD_DEVIATION 3.01 | 5.72 units on a scale STANDARD_DEVIATION 2.43 |
| Clayton Sexual Functioning Questionnaire (CSFQ) female participants - orgasm | 8.23 units on a scale STANDARD_DEVIATION 3.94 | 7.56 units on a scale STANDARD_DEVIATION 3.84 | 6.98 units on a scale STANDARD_DEVIATION 3.75 | 7.53 units on a scale STANDARD_DEVIATION 3.83 |
| Clayton Sexual Functioning Questionnaire (CSFQ) female participants - pleasure | 2.23 units on a scale STANDARD_DEVIATION 1.18 | 2.12 units on a scale STANDARD_DEVIATION 1.16 | 2.06 units on a scale STANDARD_DEVIATION 1.19 | 2.06 units on a scale STANDARD_DEVIATION 1.13 |
| Clayton Sexual Functioning Questionnaire (CSFQ) female participants - total | 36.69 units on a scale STANDARD_DEVIATION 10.43 | 35.43 units on a scale STANDARD_DEVIATION 10.73 | 35.21 units on a scale STANDARD_DEVIATION 11.68 | 34.45 units on a scale STANDARD_DEVIATION 10.09 |
| Clayton Sexual Functioning Questionnaire (CSFQ) male participants - arousal | 6.35 units on a scale STANDARD_DEVIATION 2.88 | 6.64 units on a scale STANDARD_DEVIATION 3.04 | 7.19 units on a scale STANDARD_DEVIATION 3.08 | 6.41 units on a scale STANDARD_DEVIATION 3.12 |
| Clayton Sexual Functioning Questionnaire (CSFQ) male participants - desire/frequency | 5.09 units on a scale STANDARD_DEVIATION 1.77 | 5.18 units on a scale STANDARD_DEVIATION 1.82 | 5.32 units on a scale STANDARD_DEVIATION 1.73 | 5.15 units on a scale STANDARD_DEVIATION 1.96 |
| Clayton Sexual Functioning Questionnaire (CSFQ) male participants - desire/interest | 7.91 units on a scale STANDARD_DEVIATION 2.72 | 7.90 units on a scale STANDARD_DEVIATION 2.71 | 7.71 units on a scale STANDARD_DEVIATION 2.56 | 8.06 units on a scale STANDARD_DEVIATION 2.84 |
| Clayton Sexual Functioning Questionnaire (CSFQ) male participants - orgasm | 7.21 units on a scale STANDARD_DEVIATION 2.85 | 7.49 units on a scale STANDARD_DEVIATION 2.94 | 7.77 units on a scale STANDARD_DEVIATION 2.93 | 7.51 units on a scale STANDARD_DEVIATION 3.06 |
| Clayton Sexual Functioning Questionnaire (CSFQ) male participants - pleasure | 2.50 units on a scale STANDARD_DEVIATION 1.22 | 2.41 units on a scale STANDARD_DEVIATION 1.19 | 2.43 units on a scale STANDARD_DEVIATION 1.23 | 2.30 units on a scale STANDARD_DEVIATION 1.11 |
| Clayton Sexual Functioning Questionnaire (CSFQ) male participants - total | 38.81 units on a scale STANDARD_DEVIATION 9.5 | 39.46 units on a scale STANDARD_DEVIATION 9.42 | 40.41 units on a scale STANDARD_DEVIATION 9.01 | 39.25 units on a scale STANDARD_DEVIATION 9.75 |
| Comorbidity with Generalized Anxiety Disorder (GAD) No | 138 participants | 403 participants | 131 participants | 134 participants |
| Comorbidity with Generalized Anxiety Disorder (GAD) Yes | 0 participants | 4 participants | 3 participants | 1 participants |
| Comorbidity with Major Depressive Disorder (MDD) No | 135 participants | 396 participants | 130 participants | 131 participants |
| Comorbidity with Major Depressive Disorder (MDD) Yes | 3 participants | 11 participants | 4 participants | 4 participants |
| Duration of Diabetes | 147.14 months STANDARD_DEVIATION 116.04 | 139.09 months STANDARD_DEVIATION 115.24 | 150.26 months STANDARD_DEVIATION 131.6 | 119.82 months STANDARD_DEVIATION 93.38 |
| Duration of Diabetic Peripheral Neuropathic Pain | 58.08 months STANDARD_DEVIATION 57.57 | 53.34 months STANDARD_DEVIATION 47.51 | 51.54 months STANDARD_DEVIATION 40.96 | 50.32 months STANDARD_DEVIATION 41.93 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Awakening Subscale | 88.63 units on a scale STANDARD_DEVIATION 40.75 | 89.75 units on a scale STANDARD_DEVIATION 41.59 | 93.95 units on a scale STANDARD_DEVIATION 41.55 | 86.70 units on a scale STANDARD_DEVIATION 42.46 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Behavior Following Wakefulness Subscale | 128.87 units on a scale STANDARD_DEVIATION 65.53 | 130.88 units on a scale STANDARD_DEVIATION 67.98 | 132.22 units on a scale STANDARD_DEVIATION 69.22 | 131.55 units on a scale STANDARD_DEVIATION 69.61 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Getting to Sleep Subscale | 137.61 units on a scale STANDARD_DEVIATION 62.91 | 140.45 units on a scale STANDARD_DEVIATION 62.4 | 138.62 units on a scale STANDARD_DEVIATION 59.68 | 145.22 units on a scale STANDARD_DEVIATION 64.73 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Quality of Sleep Subscale | 95.89 units on a scale STANDARD_DEVIATION 46.82 | 96.15 units on a scale STANDARD_DEVIATION 45.34 | 95.54 units on a scale STANDARD_DEVIATION 44.08 | 97.01 units on a scale STANDARD_DEVIATION 45.39 |
| Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment - Total Score | 5.73 units on a scale STANDARD_DEVIATION 1.58 | 5.86 units on a scale STANDARD_DEVIATION 1.56 | 5.91 units on a scale STANDARD_DEVIATION 1.56 | 5.94 units on a scale STANDARD_DEVIATION 1.56 |
| Race/Ethnicity, Customized Black or African American | 9 participants | 33 participants | 13 participants | 11 participants |
| Race/Ethnicity, Customized East Asian | 0 participants | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 15 participants | 33 participants | 9 participants | 9 participants |
| Race/Ethnicity, Customized Native American | 1 participants | 3 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized West Asian | 3 participants | 3 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 110 participants | 333 participants | 111 participants | 112 participants |
| Region of Enrollment Canada | 4 participants | 12 participants | 5 participants | 3 participants |
| Region of Enrollment Germany | 20 participants | 63 participants | 22 participants | 21 participants |
| Region of Enrollment Puerto Rico | 2 participants | 7 participants | 3 participants | 2 participants |
| Region of Enrollment United States | 112 participants | 325 participants | 104 participants | 109 participants |
| Sex: Female, Male Female | 55 Participants | 165 Participants | 58 Participants | 52 Participants |
| Sex: Female, Male Male | 83 Participants | 242 Participants | 76 Participants | 83 Participants |
| Sheehan Disability Scale (SDS) Global Functional Impairment Total Score | 13.49 units on a scale STANDARD_DEVIATION 9 | 12.55 units on a scale STANDARD_DEVIATION 8.58 | 11.44 units on a scale STANDARD_DEVIATION 8.72 | 12.69 units on a scale STANDARD_DEVIATION 7.92 |
| Types of Diabetes Mellitus Type I | 9 participants | 31 participants | 13 participants | 9 participants |
| Types of Diabetes Mellitus Type II | 129 participants | 376 participants | 121 participants | 126 participants |
| Weekly mean of 24 hour average pain severity | 5.81 units on a scale STANDARD_DEVIATION 1.51 | 5.76 units on a scale STANDARD_DEVIATION 1.47 | 5.69 units on a scale STANDARD_DEVIATION 1.43 | 5.78 units on a scale STANDARD_DEVIATION 1.47 |
| Weekly mean of nighttime pain severity | 5.86 units on a scale STANDARD_DEVIATION 1.74 | 5.69 units on a scale STANDARD_DEVIATION 1.97 | 5.64 units on a scale STANDARD_DEVIATION 2.06 | 5.55 units on a scale STANDARD_DEVIATION 2.11 |
| Weekly mean of the daily worst pain severity | 7.12 units on a scale STANDARD_DEVIATION 1.46 | 7.03 units on a scale STANDARD_DEVIATION 1.5 | 6.92 units on a scale STANDARD_DEVIATION 1.56 | 7.05 units on a scale STANDARD_DEVIATION 1.48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 87 / 134 | 100 / 138 | 88 / 135 |
| serious Total, serious adverse events | 6 / 134 | 3 / 138 | 5 / 135 |
Outcome results
Primary
Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine | -2.12 units on a scale | Standard Error 0.19 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine | -2.62 units on a scale | Standard Error 0.21 |
Comparison: Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin \& duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.p-value: 0.07695% CI: [-0.05, 1.04]Mixed Models Analysis
Secondary
Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores
The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, somatomotor toxicity; n=122, n=126, n=129 | 60 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, cognitive toxicity; n=126, n=129, n=128 | 75 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, total; n=122, n=126, n=128 | 8 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, cognitive toxicity; n=126, n=129, n=128 | 42 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, cognitive toxicity; n=126, n=129, n=128 | 9 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, total; n=122, n=126, n=128 | 68 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, somatomotor toxicity; n=122, n=126, n=129 | 15 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, total; n=122, n=126, n=128 | 46 participants |
| Pregabalin | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, somatomotor toxicity; n=122, n=126, n=129 | 47 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, somatomotor toxicity; n=122, n=126, n=129 | 74 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, total; n=122, n=126, n=128 | 84 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, total; n=122, n=126, n=128 | 5 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, total; n=122, n=126, n=128 | 37 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, cognitive toxicity; n=126, n=129, n=128 | 80 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, cognitive toxicity; n=126, n=129, n=128 | 6 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, cognitive toxicity; n=126, n=129, n=128 | 43 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, somatomotor toxicity; n=122, n=126, n=129 | 19 participants |
| Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, somatomotor toxicity; n=122, n=126, n=129 | 33 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, cognitive toxicity; n=126, n=129, n=128 | 41 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, total; n=122, n=126, n=128 | 38 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, somatomotor toxicity; n=122, n=126, n=129 | 74 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, total; n=122, n=126, n=128 | 4 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | worse, somatomotor toxicity; n=122, n=126, n=129 | 36 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, somatomotor toxicity; n=122, n=126, n=129 | 19 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | same, cognitive toxicity; n=126, n=129, n=128 | 5 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, cognitive toxicity; n=126, n=129, n=128 | 82 participants |
| Gabapentin + Duloxetine | Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | better, total; n=122, n=126, n=128 | 86 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.p-value: 0.13Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.p-value: 0.192Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.p-value: 0.936Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.p-value: 0.48Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.p-value: 0.69Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.p-value: 0.923Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.p-value: 0.202Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.p-value: 0.114Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.p-value: 0.954Chi-squared
Secondary
Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale
The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, lower, n=6, n=9, n=5 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, lower,n=91, n=95, n=88 | 5 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, lower, n=91, n=88, n=90 | 4 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, same, n=86, n=91, n=82 | 66 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, same,n=91, n=95, n=88 | 83 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, greater, n=93, n=95, n=90 | 2 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, same, n=86, n=90, n=83 | 65 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, greater,n=91, n=95, n=88 | 3 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, same, n=93, n=95, n=90 | 91 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, same, n=6, n=9, n=5 | 6 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, lower, n=93, n=94, n=91 | 2 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, lower, n=93, n=95, n=90 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, lower, n=86, n=91, n=82 | 13 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, same, n=93, n=94, n=91 | 91 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, greater, n=92, n=95, n=91 | 1 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, greater, n=86, n=90, n=83 | 10 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, greater, n=93, n=94, n=91 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, same, n=92, n=95, n=91 | 91 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, lower, n=84, n=87, n=86 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, lower, n=92, n=95, n=91 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, greater, n=92, n=93, n=90 | 2 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, same, n=60, n=58, n=58 | 60 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, same, n=84, n=87, n=86 | 82 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, same, n=92, n=93, n=90 | 88 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, lower, n=86, n=90, n=83 | 11 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, greater, n=84, n=87, n=86 | 2 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, lower, n=92, n=93, n=90 | 2 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, greater, n=6, n=9, n=5 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, lower, n=89, n=94, n=83 | 21 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, greater, n=91, n=92, n=91 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, same, n=89, n=94, n=83 | 44 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, greater, n=89, n=94, n=83 | 24 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, same, n=91, n=92, n=91 | 90 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, greater, n=60, n=58, n=58 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, lower,n=94, n=95, n=90 | 1 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, lower, n=91, n=92, n=91 | 1 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, greater, n=86, n=91, n=82 | 7 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, same,n=94, n=95, n=90 | 92 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, greater, n=91, n=88, n=90 | 3 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, less, n=60, n=58, n=58 | 0 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, greater,n=94, n=95, n=90 | 1 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, same, n=91, n=88, n=90 | 84 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, greater, n=91, n=92, n=91 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, greater, n=86, n=90, n=83 | 12 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, same, n=86, n=90, n=83 | 66 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, lower, n=86, n=90, n=83 | 12 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, greater, n=86, n=91, n=82 | 8 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, same, n=86, n=91, n=82 | 77 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, lower, n=86, n=91, n=82 | 6 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, greater, n=92, n=93, n=90 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, same, n=92, n=93, n=90 | 91 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, lower, n=92, n=93, n=90 | 2 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, same, n=91, n=92, n=91 | 92 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, lower, n=91, n=92, n=91 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, greater, n=91, n=88, n=90 | 1 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, same, n=91, n=88, n=90 | 84 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, lower, n=91, n=88, n=90 | 3 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, greater, n=93, n=95, n=90 | 1 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, same, n=93, n=95, n=90 | 94 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, lower, n=93, n=95, n=90 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, greater, n=92, n=95, n=91 | 1 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, same, n=92, n=95, n=91 | 94 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, lower, n=92, n=95, n=91 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, greater, n=93, n=94, n=91 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, same, n=93, n=94, n=91 | 94 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, lower, n=93, n=94, n=91 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, greater,n=91, n=95, n=88 | 4 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, same,n=91, n=95, n=88 | 85 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, lower,n=91, n=95, n=88 | 6 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, greater,n=94, n=95, n=90 | 1 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, same,n=94, n=95, n=90 | 93 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, lower,n=94, n=95, n=90 | 1 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, greater, n=89, n=94, n=83 | 20 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, same, n=89, n=94, n=83 | 46 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, lower, n=89, n=94, n=83 | 28 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, greater, n=84, n=87, n=86 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, same, n=84, n=87, n=86 | 87 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, lower, n=84, n=87, n=86 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, greater, n=6, n=9, n=5 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, same, n=6, n=9, n=5 | 8 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, lower, n=6, n=9, n=5 | 1 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, greater, n=60, n=58, n=58 | 0 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, same, n=60, n=58, n=58 | 58 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, less, n=60, n=58, n=58 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, same, n=86, n=91, n=82 | 66 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, greater,n=94, n=95, n=90 | 2 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, lower, n=91, n=92, n=91 | 1 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, less, n=60, n=58, n=58 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, same,n=94, n=95, n=90 | 87 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, same, n=91, n=92, n=91 | 89 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, same, n=6, n=9, n=5 | 5 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | phone mental health, lower,n=94, n=95, n=90 | 1 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient group visits, greater, n=91, n=92, n=91 | 1 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, greater, n=86, n=91, n=82 | 10 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, greater, n=89, n=94, n=83 | 18 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, lower, n=84, n=87, n=86 | 1 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, same, n=60, n=58, n=58 | 58 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, same, n=89, n=94, n=83 | 45 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, lower, n=92, n=93, n=90 | 4 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, lower, n=6, n=9, n=5 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nonpsychiatric visits, lower, n=89, n=94, n=83 | 20 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, same, n=92, n=93, n=90 | 84 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, lower, n=86, n=90, n=83 | 11 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, greater, n=84, n=87, n=86 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, same, n=92, n=95, n=91 | 89 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | psychiatric visits, greater, n=92, n=93, n=90 | 2 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, lower, n=92, n=95, n=91 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | nights of partial care, greater, n=92, n=95, n=91 | 2 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, greater, n=86, n=90, n=83 | 13 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, greater, n=93, n=94, n=91 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, lower, n=93, n=95, n=90 | 1 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | unpaid care, same, n=84, n=87, n=86 | 85 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, same, n=93, n=94, n=91 | 91 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, same, n=93, n=95, n=90 | 87 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours volunteered, lower, n=86, n=91, n=82 | 6 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-psychiatric, lower, n=93, n=94, n=91 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | days of partial care, greater, n=93, n=95, n=90 | 2 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | paid care, greater, n=60, n=58, n=58 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, greater,n=91, n=95, n=88 | 4 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, lower, n=91, n=88, n=90 | 5 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | hours worked, same, n=86, n=90, n=83 | 59 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, same,n=91, n=95, n=88 | 78 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, same, n=91, n=88, n=90 | 81 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | missed work caregiver, greater, n=6, n=9, n=5 | 0 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | ER visits-nonpsychiatric, lower,n=91, n=95, n=88 | 6 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale | outpatient ind. visits, greater, n=91, n=88, n=90 | 4 participants |
Secondary
Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores
14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, better; n=65, n=67, n=69 | 12 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, same; n=40, n=42, n=43 | 13 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, better; n=65, n=67, n=70 | 20 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, same; n=65, n=67, n=69 | 36 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, better; n=62, n=67, n=66 | 24 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, worse; n=42, n=42, n=45 | 17 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, worse; n=65, n=67, n=69 | 17 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, worse; n=39, n=42, n=43 | 21 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, same; n=42, n=42, n=45 | 12 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, better; n=42, n=42, n=43 | 11 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, worse; n=62, n=67, n=66 | 29 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, better; n=42, n=42, n=45 | 13 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, same; n=42, n=42, n=43 | 21 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, same; n=64, n=67, n=69 | 29 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, worse; n=65, n=67, n=70 | 26 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, worse; n=42, n=42, n=43 | 10 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, better; n=64, n=67, n=69 | 13 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, same; n=65, n=67, n=70 | 19 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, better; n=65, n=67, n=70 | 20 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, same; n=62, n=67, n=66 | 9 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, better; n=64, n=67, n=69 | 12 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, same; n=64, n=67, n=69 | 39 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, better; n=40, n=42, n=43 | 15 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, worse; n=40, n=42, n=45 | 15 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, worse; n=64, n=67, n=69 | 12 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, better; n=39, n=42, n=43 | 13 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, same; n=40, n=42, n=45 | 14 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, better; n=40, n=42, n=43 | 10 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, worse; n=40, n=42, n=43 | 12 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, better; n=40, n=42, n=45 | 11 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, same; n=40, n=42, n=43 | 23 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, worse; n=64, n=67, n=69 | 23 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, worse; n=65, n=67, n=70 | 17 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, worse; n=40, n=42, n=43 | 7 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, same; n=39, n=42, n=43 | 5 participants |
| Pregabalin | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, same; n=65, n=67, n=70 | 28 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, same; n=64, n=67, n=69 | 31 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, better; n=62, n=67, n=66 | 26 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, same; n=62, n=67, n=66 | 9 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, worse; n=62, n=67, n=66 | 32 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, better; n=39, n=42, n=43 | 23 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, same; n=39, n=42, n=43 | 5 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, worse; n=39, n=42, n=43 | 14 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, better; n=64, n=67, n=69 | 11 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, same; n=64, n=67, n=69 | 40 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, worse; n=64, n=67, n=69 | 16 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, better; n=40, n=42, n=43 | 16 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, same; n=40, n=42, n=43 | 21 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, worse; n=40, n=42, n=43 | 5 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, better; n=65, n=67, n=69 | 20 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, same; n=65, n=67, n=69 | 29 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, worse; n=65, n=67, n=69 | 18 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, better; n=42, n=42, n=43 | 12 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, same; n=42, n=42, n=43 | 21 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, worse; n=42, n=42, n=43 | 9 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, better; n=65, n=67, n=70 | 18 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, same; n=65, n=67, n=70 | 19 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, worse; n=65, n=67, n=70 | 30 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, better; n=42, n=42, n=45 | 18 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, same; n=42, n=42, n=45 | 14 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, worse; n=42, n=42, n=45 | 10 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, better; n=65, n=67, n=70 | 24 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, same; n=65, n=67, n=70 | 29 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, worse; n=65, n=67, n=70 | 14 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, better; n=40, n=42, n=45 | 18 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, same; n=40, n=42, n=45 | 10 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, worse; n=40, n=42, n=45 | 14 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, better; n=64, n=67, n=69 | 18 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, worse; n=64, n=67, n=69 | 18 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, better; n=40, n=42, n=43 | 17 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, same; n=40, n=42, n=43 | 13 participants |
| Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, worse; n=40, n=42, n=43 | 12 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, better; n=65, n=67, n=69 | 24 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, same; n=40, n=42, n=43 | 16 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, better; n=65, n=67, n=70 | 23 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, worse; n=40, n=42, n=43 | 5 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, worse; n=64, n=67, n=69 | 23 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, same; n=65, n=67, n=70 | 33 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, same; n=40, n=42, n=43 | 32 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, worse; n=62, n=67, n=66 | 24 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal, worse; n=65, n=67, n=70 | 14 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure, better; n=40, n=42, n=43 | 6 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, better; n=62, n=67, n=66 | 31 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, better; n=40, n=42, n=45 | 15 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, worse; n=64, n=67, n=69 | 16 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, better; n=40, n=42, n=43 | 11 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, same; n=40, n=42, n=45 | 16 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, same; n=64, n=67, n=69 | 32 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total, same; n=62, n=67, n=66 | 11 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal, worse; n=40, n=42, n=45 | 14 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure, better; n=64, n=67, n=69 | 21 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm, worse; n=40, n=42, n=43 | 16 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, better; n=65, n=67, n=70 | 26 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, worse; n=42, n=42, n=43 | 7 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, better; n=64, n=67, n=69 | 17 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, same; n=65, n=67, n=70 | 17 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, same; n=42, n=42, n=43 | 24 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, worse; n=39, n=42, n=43 | 18 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest, worse; n=65, n=67, n=70 | 27 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency, better; n=42, n=42, n=43 | 12 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, same; n=39, n=42, n=43 | 7 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, better; n=42, n=42, n=45 | 16 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, worse; n=65, n=67, n=69 | 22 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm, same; n=64, n=67, n=69 | 29 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, same; n=42, n=42, n=45 | 17 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency, same; n=65, n=67, n=69 | 23 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total, better; n=39, n=42, n=43 | 18 participants |
| Gabapentin + Duloxetine | Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest, worse; n=42, n=42, n=45 | 12 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.486Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.983Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.411Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.554Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.128Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.488Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.226Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.71Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.133Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.257Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.412Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.03Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.024Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.25Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.489Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.682Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.953Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.803Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.694Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.835Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.435Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.379Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.247Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.784Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.696Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.725Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.899Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.782Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.307Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.457Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.712Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.403Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.713Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.498Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.963Chi-squared
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).p-value: 0.338Chi-squared
Secondary
Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure
Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.
Time frame: baseline through 12 weeks
Population: All randomized patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | Increased blood creatinine | 0 participants |
| Pregabalin | Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | Increased blood glucose | 1 participants |
| Duloxetine | Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | Increased blood creatinine | 0 participants |
| Duloxetine | Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | Increased blood glucose | 0 participants |
| Gabapentin + Duloxetine | Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | Increased blood creatinine | 1 participants |
| Gabapentin + Duloxetine | Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure | Increased blood glucose | 0 participants |
Secondary
Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score | -2.57 units on a scale | Standard Error 0.58 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score | -3.13 units on a scale | Standard Error 0.6 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score | -2.54 units on a scale | Standard Error 0.57 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.p-value: 0.968Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.p-value: 0.492Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.p-value: 0.463Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Blood Pressure
Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Blood Pressure | Diastolic | 0.18 millimeter mercury | Standard Error 0.92 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Blood Pressure | Systolic | -3.31 millimeter mercury | Standard Error 1.44 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Blood Pressure | Diastolic | 2.24 millimeter mercury | Standard Error 0.97 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Blood Pressure | Systolic | -3.08 millimeter mercury | Standard Error 1.54 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Blood Pressure | Diastolic | -0.79 millimeter mercury | Standard Error 0.91 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Blood Pressure | Systolic | -2.08 millimeter mercury | Standard Error 1.43 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.p-value: 0.448Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.p-value: 0.118Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.p-value: 0.021Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.p-value: 0.537Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.p-value: 0.911Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.p-value: 0.627Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Body Weight
Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Body Weight | 1.00 kilogram | Standard Error 0.36 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Body Weight | -2.39 kilogram | Standard Error 0.38 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Body Weight | -1.06 kilogram | Standard Error 0.36 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.p-value: <0.001Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.p-value: <0.001Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.p-value: 0.011Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | baseline | 4.38 units on a scale | Standard Error 3.08 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | change | -1.82 units on a scale | Standard Error 0.22 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | baseline | 4.63 units on a scale | Standard Error 2.96 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | change | -2.09 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | baseline | 5.02 units on a scale | Standard Error 2.68 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life | change | -2.33 units on a scale | Standard Error 0.23 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.p-value: 0.09895% CI: [-0.1, 1.13]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.p-value: 0.38395% CI: [-0.35, 0.9]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.p-value: 0.45295% CI: [-0.86, 0.39]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | baseline | 4.24 units on a scale | Standard Error 2.67 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | change | -1.51 units on a scale | Standard Error 0.22 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | baseline | 5.03 units on a scale | Standard Error 2.65 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | change | -2.38 units on a scale | Standard Error 0.23 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | baseline | 5.03 units on a scale | Standard Error 2.48 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity | change | -1.86 units on a scale | Standard Error 0.22 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.p-value: 0.26395% CI: [-0.26, 0.95]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.p-value: 0.00795% CI: [0.24, 1.49]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.p-value: 0.10295% CI: [-0.1, 1.13]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | baseline | 3.42 units on a scale | Standard Error 2.73 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | change | -1.46 units on a scale | Standard Error 0.21 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | baseline | 4.08 units on a scale | Standard Error 2.66 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | change | -1.85 units on a scale | Standard Error 0.23 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | baseline | 4.10 units on a scale | Standard Error 2.67 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood | change | -1.43 units on a scale | Standard Error 0.21 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.p-value: 0.92295% CI: [-0.61, 0.55]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.p-value: 0.19595% CI: [-0.2, 0.99]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.p-value: 0.16295% CI: [-0.17, 1.02]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | baseline | 4.61 units on a scale | Standard Error 2.86 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | change | -1.63 units on a scale | Standard Error 0.24 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | baseline | 4.98 units on a scale | Standard Error 2.86 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | change | -1.86 units on a scale | Standard Error 0.25 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | baseline | 5.15 units on a scale | Standard Error 2.54 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work | change | -1.88 units on a scale | Standard Error 0.24 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.p-value: 0.45195% CI: [-0.4, 0.9]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.p-value: 0.48595% CI: [-0.43, 0.9]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.p-value: 0.96995% CI: [-0.68, 0.65]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | baseline | 2.96 units on a scale | Standard Error 2.68 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | change | -0.97 units on a scale | Standard Error 0.21 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | baseline | 3.08 units on a scale | Standard Error 2.72 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | change | -1.27 units on a scale | Standard Error 0.22 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | baseline | 3.29 units on a scale | Standard Error 2.58 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People | change | -1.17 units on a scale | Standard Error 0.21 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.p-value: 0.47995% CI: [-0.36, 0.76]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.p-value: 0.30195% CI: [-0.27, 0.87]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.p-value: 0.73195% CI: [-0.47, 0.67]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | baseline | 4.91 units on a scale | Standard Error 2.87 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | change | -2.29 units on a scale | Standard Error 0.24 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | baseline | 4.97 units on a scale | Standard Error 2.94 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | change | -2.12 units on a scale | Standard Error 0.26 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | baseline | 5.40 units on a scale | Standard Error 2.81 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep | change | -2.50 units on a scale | Standard Error 0.24 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.p-value: 0.52895% CI: [-0.45, 0.87]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.p-value: 0.62695% CI: [-0.84, 0.51]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.p-value: 0.2795% CI: [-1.06, 0.3]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | baseline | 5.25 units on a scale | Standard Error 2.72 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | change | -1.88 units on a scale | Standard Error 0.24 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | baseline | 5.52 units on a scale | Standard Error 2.85 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | change | -2.56 units on a scale | Standard Error 0.26 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | baseline | 5.79 units on a scale | Standard Error 2.53 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability | change | -2.09 units on a scale | Standard Error 0.24 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.p-value: 0.54195% CI: [-0.46, 0.87]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.p-value: 0.05195% CI: [0, 1.36]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.p-value: 0.17395% CI: [-0.21, 1.15]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | baseline | 4.25 units on a scale | Standard Error 2.34 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | change | -1.62 units on a scale | Standard Error 0.2 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | baseline | 4.61 units on a scale | Standard Error 2.36 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | change | -2.00 units on a scale | Standard Error 0.21 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | baseline | 4.83 units on a scale | Standard Error 2.13 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score | change | -1.90 units on a scale | Standard Error 0.2 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.p-value: 0.30995% CI: [-0.26, 0.82]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.p-value: 0.17495% CI: [-0.17, 0.93]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.p-value: 0.71795% CI: [-0.45, 0.65]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | baseline | 5.53 units on a scale | Standard Error 1.87 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | change | -1.80 units on a scale | Standard Error 0.2 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | baseline | 5.65 units on a scale | Standard Error 1.72 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | change | -2.44 units on a scale | Standard Error 0.21 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | baseline | 5.75 units on a scale | Standard Error 1.76 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain | change | -2.29 units on a scale | Standard Error 0.2 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.p-value: 0.07895% CI: [-0.06, 1.04]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.p-value: 0.02595% CI: [0.08, 1.2]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.p-value: 0.60295% CI: [-0.41, 0.7]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | baseline | 4.23 units on a scale | Standard Error 2.28 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | change | -1.27 units on a scale | Standard Error 0.19 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | baseline | 4.18 units on a scale | Standard Error 2.11 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | change | -1.55 units on a scale | Standard Error 0.2 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | baseline | 4.07 units on a scale | Standard Error 2.14 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain | change | -1.54 units on a scale | Standard Error 0.19 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.p-value: 0.29895% CI: [-0.25, 0.8]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.p-value: 0.30495% CI: [-0.25, 0.81]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.p-value: 0.98995% CI: [-0.53, 0.54]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | baseline | 4.98 units on a scale | Standard Error 2.33 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | change | -1.77 units on a scale | Standard Error 0.21 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | baseline | 5.03 units on a scale | Standard Error 2.3 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | change | -2.24 units on a scale | Standard Error 0.22 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | baseline | 5.36 units on a scale | Standard Error 2.18 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now | change | -2.19 units on a scale | Standard Error 0.21 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.p-value: 0.14595% CI: [-0.14, 0.97]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.p-value: 0.11295% CI: [-0.11, 1.03]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.p-value: 0.86595% CI: [-0.52, 0.62]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 Weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | baseline | 6.73 units on a scale | Standard Error 2.01 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | change | -2.34 units on a scale | Standard Error 0.23 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | baseline | 6.87 units on a scale | Standard Error 2.06 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | change | -3.02 units on a scale | Standard Error 0.25 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | baseline | 7.00 units on a scale | Standard Error 1.83 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain | change | -2.64 units on a scale | Standard Error 0.23 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.p-value: 0.35395% CI: [-0.34, 0.94]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.p-value: 0.03995% CI: [0.03, 1.34]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.p-value: 0.24495% CI: [-0.27, 1.04]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | baseline | 4.27 units on a scale | Standard Error 0.85 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | change | -1.06 units on a scale | Standard Error 0.1 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | baseline | 4.47 units on a scale | Standard Error 0.9 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | change | -1.16 units on a scale | Standard Error 0.1 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | baseline | 4.40 units on a scale | Standard Error 0.79 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) | change | -1.13 units on a scale | Standard Error 0.1 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.p-value: 0.60295% CI: [-0.2, 0.35]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.p-value: 0.46995% CI: [-0.17, 0.37]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.p-value: 0.84195% CI: [-0.24, 0.3]t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | baseline | 8.24 millimole/liter | Standard Deviation 3.31 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | change | 0.16 millimole/liter | Standard Deviation 3.97 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | baseline | 8.45 millimole/liter | Standard Deviation 3.65 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | change | 0.19 millimole/liter | Standard Deviation 2.86 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | baseline | 7.99 millimole/liter | Standard Deviation 3.82 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose | change | 0.67 millimole/liter | Standard Deviation 2.75 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.p-value: 0.047t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.p-value: 0.232t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.p-value: 0.424t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Heart Rate
Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Heart Rate | -1.30 beats per minute | Standard Error 0.97 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Heart Rate | 0.80 beats per minute | Standard Error 1.02 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Heart Rate | 1.05 beats per minute | Standard Error 0.96 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.p-value: 0.078Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.p-value: 0.13Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.p-value: 0.85Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Hemoglobin A1C
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | baseline | 7.57 percent | Standard Deviation 1.61 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | change | -0.12 percent | Standard Deviation 1 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | baseline | 7.51 percent | Standard Deviation 1.44 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | change | -0.01 percent | Standard Deviation 0.71 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | baseline | 7.16 percent | Standard Deviation 1.44 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hemoglobin A1C | change | 0.07 percent | Standard Deviation 0.8 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.p-value: 0.298t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.p-value: 0.987t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.p-value: 0.297t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels
Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, AST, n=119, n=121, n=118 | 1.12 units/liter | Standard Deviation 7.62 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, AST, n=119, n=121, n=118 | 22.55 units/liter | Standard Deviation 7.64 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, ALT, n=120, n=122, n=120 | 23.88 units/liter | Standard Deviation 10.14 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, ALT, n=120, n=122, n=120 | -0.13 units/liter | Standard Deviation 7.86 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, GGT, n=121, n=123, n=120 | 40.80 units/liter | Standard Deviation 53.08 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, GGT, n=121, n=123, n=120 | 1.17 units/liter | Standard Deviation 39.35 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, AlkPhos, n=121, n=123, n=120 | 84.97 units/liter | Standard Deviation 29.36 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, AlkPhos, n=121, n=123, n=120 | 2.80 units/liter | Standard Deviation 40.32 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, ALT, n=120, n=122, n=120 | 25.04 units/liter | Standard Deviation 13.18 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, AlkPhos, n=121, n=123, n=120 | 83.74 units/liter | Standard Deviation 38.27 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, ALT, n=120, n=122, n=120 | -0.16 units/liter | Standard Deviation 10.45 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, GGT, n=121, n=123, n=120 | 34.29 units/liter | Standard Deviation 25.53 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, GGT, n=121, n=123, n=120 | -3.03 units/liter | Standard Deviation 15.56 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, AST, n=119, n=121, n=118 | 22.84 units/liter | Standard Deviation 8.7 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, AST, n=119, n=121, n=118 | -0.52 units/liter | Standard Deviation 6.82 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, AlkPhos, n=121, n=123, n=120 | 0.55 units/liter | Standard Deviation 18.21 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, ALT, n=120, n=122, n=120 | 24.39 units/liter | Standard Deviation 10.79 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, GGT, n=121, n=123, n=120 | -2.55 units/liter | Standard Deviation 22.85 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, AST, n=119, n=121, n=118 | -0.48 units/liter | Standard Deviation 7.71 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, ALT, n=120, n=122, n=120 | 0.03 units/liter | Standard Deviation 9.53 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, AlkPhos, n=121, n=123, n=120 | 82.18 units/liter | Standard Deviation 28.39 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, AST, n=119, n=121, n=118 | 23.42 units/liter | Standard Deviation 8.19 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | baseline, GGT, n=121, n=123, n=120 | 43.93 units/liter | Standard Deviation 48.45 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels | change, AlkPhos, n=121, n=123, n=120 | 1.78 units/liter | Standard Deviation 12.84 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.p-value: 0.055t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.p-value: 0.051t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.p-value: 0.993t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.p-value: 0.928t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.p-value: 0.609t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.p-value: 0.675t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.p-value: 0.985t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.p-value: 0.847t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.p-value: 0.832t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.p-value: 0.169t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.p-value: 0.91t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.p-value: 0.134t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)
The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | GTS, n=122, n=119, n=118 | 10.96 units on a scale | Standard Error 4.83 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | QOS, n=121, n=118, n=118 | 9.32 units on a scale | Standard Error 4.01 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | AFS, n=122, n=118, n=118 | 10.02 units on a scale | Standard Error 3.71 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | BFW, n=124, n=115, n=118 | 19.67 units on a scale | Standard Error 5.65 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | BFW, n=124, n=115, n=118 | 21.04 units on a scale | Standard Error 6.03 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | GTS, n=122, n=119, n=118 | 17.40 units on a scale | Standard Error 5.06 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | AFS, n=122, n=118, n=118 | 8.14 units on a scale | Standard Error 3.92 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | QOS, n=121, n=118, n=118 | 7.39 units on a scale | Standard Error 4.24 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | BFW, n=124, n=115, n=118 | 14.33 units on a scale | Standard Error 5.77 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | QOS, n=121, n=118, n=118 | 9.64 units on a scale | Standard Error 4.06 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | AFS, n=122, n=118, n=118 | 11.86 units on a scale | Standard Error 3.73 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) | GTS, n=122, n=119, n=118 | 14.75 units on a scale | Standard Error 4.92 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.p-value: 0.572Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.p-value: 0.345Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.p-value: 0.699Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.p-value: 0.954Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.p-value: 0.734Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.p-value: 0.693Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.p-value: 0.72Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.p-value: 0.722Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.p-value: 0.48Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.p-value: 0.498Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.p-value: 0.865Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.p-value: 0.408Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores
The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | cognitive toxicity, n=126, n=129, n=128 | -5.12 units on a scale | Standard Error 1.18 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | total, n=122, n=126, n=128 | -6.27 units on a scale | Standard Error 1.63 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | somatomotor toxicity, n=122, n=126, n=129 | -1.36 units on a scale | Standard Error 0.51 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | cognitive toxicity, n=126, n=129, n=128 | -6.23 units on a scale | Standard Error 1.23 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | total, n=122, n=126, n=128 | -8.92 units on a scale | Standard Error 1.7 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | somatomotor toxicity, n=122, n=126, n=129 | -2.58 units on a scale | Standard Error 0.54 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | total, n=122, n=126, n=128 | -7.29 units on a scale | Standard Error 1.59 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | somatomotor toxicity, n=122, n=126, n=129 | -1.91 units on a scale | Standard Error 0.5 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores | cognitive toxicity, n=126, n=129, n=128 | -5.29 units on a scale | Standard Error 1.16 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.p-value: 0.645Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.p-value: 0.248Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.p-value: 0.47Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.p-value: 0.914Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.p-value: 0.505Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.p-value: 0.57Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.p-value: 0.43Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.p-value: 0.09Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.p-value: 0.341Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores
14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total; n=62, n=67, n=66 | -0.53 units on a scale | Standard Error 0.8 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total; n=39; n=42, n=43 | -0.01 units on a scale | Standard Error 1.1 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure; n=64, n=67, n=69 | 0.08 units on a scale | Standard Error 0.12 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure; n=40, n=42, n=43 | 0.15 units on a scale | Standard Error 0.16 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency; n=65, n=67, n=69 | -0.02 units on a scale | Standard Error 0.16 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency; n=42, n=42, n=43 | 0.21 units on a scale | Standard Error 0.21 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest; n=65, n=67, n=70 | -0.27 units on a scale | Standard Error 0.24 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest; n=42, n=42, n=45 | -0.17 units on a scale | Standard Error 0.32 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal; n=65, n=67, n=70 | 0.17 units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal; n=40, n=42, n=45 | -0.11 units on a scale | Standard Error 0.34 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm; n=64, n=67, n=69 | -0.39 units on a scale | Standard Error 0.27 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm; n=40, n=42, n=43 | 0.31 units on a scale | Standard Error 0.39 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm; n=40, n=42, n=43 | -0.05 units on a scale | Standard Error 0.4 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total; n=62, n=67, n=66 | 0.48 units on a scale | Standard Error 0.77 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest; n=65, n=67, n=70 | -0.19 units on a scale | Standard Error 0.24 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal; n=65, n=67, n=70 | 0.52 units on a scale | Standard Error 0.26 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total; n=39; n=42, n=43 | 1.12 units on a scale | Standard Error 1.1 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency; n=42, n=42, n=43 | 0.26 units on a scale | Standard Error 0.22 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm; n=64, n=67, n=69 | 0.18 units on a scale | Standard Error 0.26 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure; n=64, n=67, n=69 | -0.06 units on a scale | Standard Error 0.11 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest; n=42, n=42, n=45 | 0.34 units on a scale | Standard Error 0.33 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency; n=65, n=67, n=69 | 0.06 units on a scale | Standard Error 0.16 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure; n=40, n=42, n=43 | 0.47 units on a scale | Standard Error 0.16 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal; n=40, n=42, n=45 | 0.07 units on a scale | Standard Error 0.35 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, pleasure; n=40, n=42, n=43 | -0.09 units on a scale | Standard Error 0.16 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/frequency; n=65, n=67, n=69 | 0.16 units on a scale | Standard Error 0.16 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, arousal; n=40, n=42, n=45 | -0.30 units on a scale | Standard Error 0.33 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/frequency; n=42, n=42, n=43 | 0.30 units on a scale | Standard Error 0.21 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, desire/interest; n=65, n=67, n=70 | 0.05 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, desire/interest; n=42, n=42, n=45 | 0.01 units on a scale | Standard Error 0.32 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, orgasm; n=64, n=67, n=69 | 0.17 units on a scale | Standard Error 0.26 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, total; n=62, n=67, n=66 | 1.29 units on a scale | Standard Error 0.79 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, total; n=39; n=42, n=43 | -0.61 units on a scale | Standard Error 1.08 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, arousal; n=65, n=67, n=70 | 0.52 units on a scale | Standard Error 0.26 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | male, pleasure; n=64, n=67, n=69 | 0.13 units on a scale | Standard Error 0.11 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores | female, orgasm; n=40, n=42, n=43 | -0.85 units on a scale | Standard Error 0.39 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.p-value: 0.09695% CI: [-3.96, 0.32]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.p-value: 0.35395% CI: [-3.16, 1.13]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.p-value: 0.44495% CI: [-1.27, 2.88]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.p-value: 0.68295% CI: [-2.29, 3.48]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.p-value: 0.4595% CI: [-4.08, 1.82]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.p-value: 0.21895% CI: [-4.49, 1.04]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.p-value: 0.74795% CI: [-0.36, 0.26]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.p-value: 0.3995% CI: [-0.18, 0.45]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.p-value: 0.22895% CI: [-0.12, 0.49]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.p-value: 0.2695% CI: [-0.18, 0.67]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.p-value: 0.14195% CI: [-0.76, 0.11]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.p-value: 0.00795% CI: [-0.98, -0.16]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.p-value: 0.40995% CI: [-0.61, 0.25]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.p-value: 0.71595% CI: [-0.51, 0.35]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.p-value: 0.64195% CI: [-0.32, 0.52]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.p-value: 0.76795% CI: [-0.64, 0.47]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.p-value: 0.88195% CI: [-0.61, 0.52]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.p-value: 0.88595% CI: [-0.51, 0.59]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.p-value: 0.32595% CI: [-0.96, 0.32]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.p-value: 0.79895% CI: [-0.73, 0.56]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.p-value: 0.46195% CI: [-0.39, 0.87]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.p-value: 0.6795% CI: [-1.02, 0.66]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.p-value: 0.24395% CI: [-1.37, 0.35]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.p-value: 0.42395% CI: [-1.14, 0.48]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.p-value: 0.33395% CI: [-1.04, 0.35]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.p-value: 0.33495% CI: [-1.05, 0.36]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.p-value: 0.9995% CI: [-0.69, 0.68]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.p-value: 0.66595% CI: [-0.7, 1.09]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.p-value: 0.795% CI: [-1.1, 0.74]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.p-value: 0.38695% CI: [-1.23, 0.48]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.p-value: 0.1295% CI: [-1.27, 0.15]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.p-value: 0.11995% CI: [-1.29, 0.15]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.p-value: 0.97695% CI: [-0.71, 0.69]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.p-value: 0.02695% CI: [0.14, 2.2]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.p-value: 0.49795% CI: [-0.69, 1.42]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.p-value: 0.11295% CI: [-1.8, 0.19]t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Total | -4.96 units on a scale | Standard Error 0.66 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 1 | -1.96 units on a scale | Standard Error 0.31 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 2 | -1.64 units on a scale | Standard Error 0.24 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 3 | -1.70 units on a scale | Standard Error 0.22 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 3 | -1.17 units on a scale | Standard Error 0.22 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Total | -3.47 units on a scale | Standard Error 0.65 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 2 | -1.12 units on a scale | Standard Error 0.23 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 1 | -1.21 units on a scale | Standard Error 0.33 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 3 | -1.54 units on a scale | Standard Error 0.22 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 1 | -1.95 units on a scale | Standard Error 0.32 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Item 2 | -1.53 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 | Total | -4.54 units on a scale | Standard Error 0.66 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.p-value: 0.63595% CI: [-2.18, 1.33]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.p-value: 0.09295% CI: [-3.24, 0.24]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.p-value: 0.22195% CI: [-2.8, 0.65]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.p-value: 0.97495% CI: [-0.88, 0.85]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.p-value: 0.09395% CI: [-1.63, 0.13]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.p-value: 0.09195% CI: [-1.59, 0.12]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.p-value: 0.73395% CI: [-0.75, 0.52]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.p-value: 0.10295% CI: [-1.15, 0.11]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.p-value: 0.19395% CI: [-1.04, 0.21]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.p-value: 0.58495% CI: [-0.76, 0.43]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.p-value: 0.07795% CI: [-1.12, 0.06]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.p-value: 0.22195% CI: [-0.95, 0.22]t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Total Bilirubin
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Total Bilirubin | baseline | 8.43 micromole/liter | Standard Deviation 4.5 |
| Pregabalin | Mean Change From Baseline to 12 Weeks in Total Bilirubin | change | -0.51 micromole/liter | Standard Deviation 3.48 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Total Bilirubin | baseline | 8.07 micromole/liter | Standard Deviation 3.99 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Total Bilirubin | change | -0.28 micromole/liter | Standard Deviation 2.6 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Total Bilirubin | baseline | 8.23 micromole/liter | Standard Deviation 5.07 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Total Bilirubin | change | -0.42 micromole/liter | Standard Deviation 3.39 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.p-value: 0.285t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.p-value: 0.505t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.p-value: 0.679t-test, 2 sided
Secondary
Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin | -2.39 units on a scale | Standard Error 0.2 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin | -2.62 units on a scale | Standard Error 0.21 |
Comparison: Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine \& duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.p-value: 0.41795% CI: [-0.32, 0.78]Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity | -2.30 units on a scale | Standard Error 0.21 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity | -2.71 units on a scale | Standard Error 0.22 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity | -2.49 units on a scale | Standard Error 0.21 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.p-value: 0.463Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.p-value: 0.52Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.p-value: 0.463Mixed Models Analysis
Secondary
Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score | -2.59 units on a scale | Standard Error 0.22 |
| Duloxetine | Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score | -3.08 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score | -2.86 units on a scale | Standard Error 0.23 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.p-value: 0.389Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.p-value: 0.126Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.p-value: 0.489Mixed Models Analysis
Secondary
Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks | 65 participants |
| Duloxetine | Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks | 68 participants |
| Gabapentin + Duloxetine | Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks | 72 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.p-value: 0.975Mantel Haenszel
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.p-value: 0.448Mantel Haenszel
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.p-value: 0.28Mantel Haenszel
Secondary
Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks | 59 participants |
| Duloxetine | Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks | 64 participants |
| Gabapentin + Duloxetine | Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks | 68 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.p-value: 0.905Mantel Haenszel
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.p-value: 0.368Mantel Haenszel
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.p-value: 0.2Mantel Haenszel
Secondary
Number of Participants With Treatment-Emergent Changes in Body Weight
Treatment-emergent high body weight: weight at last visit \>=107% of baseline weight. Treatment-emergent low body weight: weight at last visit \<=93% of baseline weight.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Treatment-Emergent Changes in Body Weight | high | 6 participants |
| Pregabalin | Number of Participants With Treatment-Emergent Changes in Body Weight | low | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Changes in Body Weight | high | 1 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Changes in Body Weight | low | 10 participants |
| Gabapentin + Duloxetine | Number of Participants With Treatment-Emergent Changes in Body Weight | high | 3 participants |
| Gabapentin + Duloxetine | Number of Participants With Treatment-Emergent Changes in Body Weight | low | 8 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.p-value: 0.332Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.p-value: 0.065Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.p-value: 0.622Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.p-value: 0.103Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.p-value: 0.034Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.p-value: 0.808Fisher Exact
Secondary
Number of Participants With Treatment-emergent Elevated Blood Pressure
Elevated systolic blood pressure: \>=130 millimeter mercury (mm Hg) + an increase of \>=10 mm Hg if baseline \<130 mm Hg. Elevated diastolic blood pressure: \>=85 mm Hg + an increase of \>=10 mm Hg if baseline \<85 mm Hg.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Treatment-emergent Elevated Blood Pressure | diastolic, n=94, n=98, n=100 | 11 participants |
| Pregabalin | Number of Participants With Treatment-emergent Elevated Blood Pressure | systolic, n=42, n=39, n=56 | 20 participants |
| Duloxetine | Number of Participants With Treatment-emergent Elevated Blood Pressure | diastolic, n=94, n=98, n=100 | 12 participants |
| Duloxetine | Number of Participants With Treatment-emergent Elevated Blood Pressure | systolic, n=42, n=39, n=56 | 15 participants |
| Gabapentin + Duloxetine | Number of Participants With Treatment-emergent Elevated Blood Pressure | diastolic, n=94, n=98, n=100 | 13 participants |
| Gabapentin + Duloxetine | Number of Participants With Treatment-emergent Elevated Blood Pressure | systolic, n=42, n=39, n=56 | 16 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.p-value: 0.83Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.p-value: 1Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.p-value: 1Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.p-value: 0.06Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.p-value: 0.502Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.p-value: 0.376Fisher Exact
Secondary
Number of Participants With Treatment-Emergent Elevated Heart Rate
Elevated heart rate: \>=100 beats per minute (bpm) + an increase of \>=10 bpm if baseline \<100 bpm.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With Treatment-Emergent Elevated Heart Rate | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Elevated Heart Rate | 9 participants |
| Gabapentin + Duloxetine | Number of Participants With Treatment-Emergent Elevated Heart Rate | 6 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.p-value: 0.281Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.p-value: 0.06Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.p-value: 0.596Fisher Exact
Secondary
Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score | 48 participants |
| Duloxetine | Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score | 50 participants |
| Gabapentin + Duloxetine | Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score | 47 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.p-value: 0.548Mantel Haenszel
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.p-value: 0.599Mantel Haenszel
Comparison: Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.p-value: 1Mantel Haenszel
Secondary
Number of Patients With Treatment-Emergent Elevated Laboratory Analytes
Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): \>34, male (m): \>36. Alanine Aminotransferase (ALT): f:\<69 years (yr) \>34, ≥69yr \>32; m: \<69yr \>43, ≥69yr \>35. Total Bilirubin (TBili): \>21. Gamma Glutamyl Transferase (GGT): f: \<59yr \>49, ≥59yr \>50; m: \<59yr \>61, ≥59yr \>50. Fasting Plasma Glucose (FPG): \<59yr \>6.4, ≥59yr \>6.7. Hemoglobin A1C (HbA1C) \>6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr \>106, 50-70yr \>123, 70-80yr \>164, ≥80yr \>221; m: 18-50yr \>129, 50-70yr \>131, 70-80yr \>156, ≥80yr \>187
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | TBili, n=119, n=121, n=116 | 2 participants |
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | AlkPhos, n=112, n=114, n=113 | 4 participants |
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | FPG, n=33, n=30, n=36 | 7 participants |
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | GGT, n=102, n=105, n=96 | 2 participants |
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | ALT, n=111, n=104, n=110 | 3 participants |
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | AST, n=113, n=116, n=109 | 4 participants |
| Pregabalin | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | HbA1C, n=17, n=18, n=29 | 6 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | AST, n=113, n=116, n=109 | 6 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | FPG, n=33, n=30, n=36 | 11 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | ALT, n=111, n=104, n=110 | 6 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | TBili, n=119, n=121, n=116 | 0 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | GGT, n=102, n=105, n=96 | 6 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | HbA1C, n=17, n=18, n=29 | 2 participants |
| Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | AlkPhos, n=112, n=114, n=113 | 3 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | FPG, n=33, n=30, n=36 | 18 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | ALT, n=111, n=104, n=110 | 10 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | AlkPhos, n=112, n=114, n=113 | 4 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | HbA1C, n=17, n=18, n=29 | 10 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | AST, n=113, n=116, n=109 | 4 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | GGT, n=102, n=105, n=96 | 6 participants |
| Gabapentin + Duloxetine | Number of Patients With Treatment-Emergent Elevated Laboratory Analytes | TBili, n=119, n=121, n=116 | 0 participants |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.p-value: 1Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.p-value: 0.749Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.p-value: 0.75Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.p-value: 0.05Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.p-value: 0.32Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.p-value: 0.44Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.p-value: 0.498Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.p-value: 0.245Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.p-value: 0.16Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.p-value: 0.28Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.p-value: 1Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.p-value: 0.023Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.p-value: 0.264Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.p-value: 0.325Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.p-value: 1Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.p-value: 0.121Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.p-value: 0.095Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.p-value: 1Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.p-value: 0.72Fisher Exact
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.p-value: 0.722Fisher Exact
Secondary
Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms
Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms | Direct Treatment Effect | -0.449 coefficient |
| Pregabalin | Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms | Indirect Treatment Effect | 0.014 coefficient |
| Pregabalin | Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms | Total Treatment Effect | -0.435 coefficient |
p-value: 0.107Regression, Linear
Secondary
Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks | 3.03 units on a scale | Standard Deviation 1.19 |
| Duloxetine | Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks | 3.01 units on a scale | Standard Deviation 1.68 |
| Gabapentin + Duloxetine | Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks | 2.83 units on a scale | Standard Deviation 1.27 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.p-value: 0.27695% CI: [-0.16, 0.55]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.p-value: 0.92995% CI: [-0.33, 0.37]t-test, 2 sided
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.p-value: 0.31395% CI: [-0.53, 0.17]t-test, 2 sided
Secondary
Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation
Time frame: baseline through 12 weeks
Population: All participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Anorgasmia | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Fatigue | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Somnolence | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Enterovirus Infection | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Increased Blood Creatine | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Rash | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dry mouth | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Increased Blood Glucose | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Pulomnary Embolism | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Diarrhoea | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Bruxism | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Anxiety | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dermatitis | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Cerebrovascular Accident | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Vomiting | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Depression | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Chest Discomfort | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Pollakiuria | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dizziness | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Peripheral Oedema | 5 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Myoclonus | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dysuria | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Urticaria | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Muscular Weakness | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Mental Impairment | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Headache | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Lymphoma | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Loss of Consciousness | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Hyperhidrosis | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Insomnia | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Lacunar Infarction | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Sedation | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Nausea | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Facial Hypoaesthesia | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Allergic Oedema | 1 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Sleep Disorder | 0 participants |
| Pregabalin | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Generalized Oedema | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Headache | 2 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Rash | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Peripheral Oedema | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Nausea | 4 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Insomnia | 4 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Somnolence | 2 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Anxiety | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dizziness | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dysuria | 2 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Hyperhidrosis | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Sedation | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Allergic Oedema | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Anorgasmia | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Increased Blood Creatine | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Increased Blood Glucose | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Bruxism | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Cerebrovascular Accident | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Chest Discomfort | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Depression | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dermatitis | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Diarrhoea | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dry mouth | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Enterovirus Infection | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Fatigue | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Generalized Oedema | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Facial Hypoaesthesia | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Lacunar Infarction | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Loss of Consciousness | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Lymphoma | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Mental Impairment | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Muscular Weakness | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Myoclonus | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Pollakiuria | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Pulomnary Embolism | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Sleep Disorder | 1 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Urticaria | 0 participants |
| Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Vomiting | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Vomiting | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Generalized Oedema | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Sedation | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Somnolence | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Facial Hypoaesthesia | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Hyperhidrosis | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Urticaria | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Lacunar Infarction | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Headache | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Rash | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Loss of Consciousness | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Pulomnary Embolism | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Insomnia | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Lymphoma | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dysuria | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Nausea | 4 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Mental Impairment | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dry mouth | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Chest Discomfort | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Cerebrovascular Accident | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Sleep Disorder | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Depression | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Bruxism | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Muscular Weakness | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dermatitis | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Increased Blood Glucose | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Dizziness | 2 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Diarrhoea | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Increased Blood Creatine | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Peripheral Oedema | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Anorgasmia | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Myoclonus | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Enterovirus Infection | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Pollakiuria | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Anxiety | 1 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Fatigue | 0 participants |
| Gabapentin + Duloxetine | Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation | Allergic Oedema | 0 participants |
Secondary
Summary of Number of Participants Who Discontinued
Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Summary of Number of Participants Who Discontinued | 38 participants |
| Duloxetine | Summary of Number of Participants Who Discontinued | 51 participants |
| Gabapentin + Duloxetine | Summary of Number of Participants Who Discontinued | 36 participants |
Secondary
Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score
This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score | 56.0 days |
| Duloxetine | Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score | 35.0 days |
| Gabapentin + Duloxetine | Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score | 28.0 days |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.p-value: 0.008Log Rank
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.p-value: 0.033Log Rank
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.p-value: 0.688Log Rank
Secondary
Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score
This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score | 35.0 days |
| Duloxetine | Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score | 28.0 days |
| Gabapentin + Duloxetine | Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score | 28.0 days |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.p-value: 0.103Log Rank
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.p-value: 0.167Log Rank
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.p-value: 0.919Log Rank
Secondary
Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score
This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Secondary
Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score
This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.
Time frame: baseline through 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Secondary
Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)
Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.
Time frame: baseline, 12 weeks
Population: The per-protocol sub-population of all randomized participants with a baseline value and \>= 1 non-missing post-baseline value (modified intent-to-treat population) was included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | baseline | 5.74 units on a scale | Standard Error 1.3 |
| Pregabalin | Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | change | -2.12 units on a scale | Standard Error 0.23 |
| Duloxetine | Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | baseline | 6.02 units on a scale | Standard Error 1.6 |
| Duloxetine | Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | change | -2.58 units on a scale | Standard Error 0.27 |
| Gabapentin + Duloxetine | Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | baseline | 5.74 units on a scale | Standard Error 1.42 |
| Gabapentin + Duloxetine | Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) | change | -2.40 units on a scale | Standard Error 0.23 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.p-value: 0.36595% CI: [-0.33, 0.9]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.p-value: 0.17295% CI: [-0.2, 1.13]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.p-value: 0.59495% CI: [-0.49, 0.85]Mixed Models Analysis
Secondary
Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for \<56 contiguous days prior to randomization. Prior use: use of gabapentin for \>=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks
Population: Analyzed were all participants with a baseline and at least 1 non-missing post-baseline value. Last observation carried forward analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 8 | -1.89 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 3 | -1.18 units on a scale | Standard Error 0.2 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 4 | -1.64 units on a scale | Standard Error 0.21 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 5 | -1.72 units on a scale | Standard Error 0.22 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 6 | -1.92 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 7 | -1.93 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 2 | -0.70 units on a scale | Standard Error 0.19 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 9 | -2.04 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 10 | -2.14 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 11 | -2.27 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 12 | -2.39 units on a scale | Standard Error 0.23 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, baseline | 5.24 units on a scale | Standard Error 1.07 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 1 | -0.22 units on a scale | Standard Error 0.24 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 2 | -0.39 units on a scale | Standard Error 0.27 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 3 | -0.71 units on a scale | Standard Error 0.3 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 4 | -0.84 units on a scale | Standard Error 0.32 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 5 | -0.95 units on a scale | Standard Error 0.33 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 6 | -1.09 units on a scale | Standard Error 0.34 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 7 | -1.08 units on a scale | Standard Error 0.34 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 8 | -1.26 units on a scale | Standard Error 0.35 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 9 | -1.21 units on a scale | Standard Error 0.34 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 10 | -1.42 units on a scale | Standard Error 0.35 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 11 | -1.48 units on a scale | Standard Error 0.35 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 12 | -1.62 units on a scale | Standard Error 0.36 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, baseline | 5.91 units on a scale | Standard Error 1.55 |
| Pregabalin | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 1 | -0.30 units on a scale | Standard Error 0.17 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 10 | -2.45 units on a scale | Standard Error 0.24 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 9 | -2.89 units on a scale | Standard Error 0.38 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 11 | -2.46 units on a scale | Standard Error 0.24 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 12 | -2.46 units on a scale | Standard Error 0.24 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, baseline | 5.99 units on a scale | Standard Error 1.52 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, baseline | 5.39 units on a scale | Standard Error 1.48 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 10 | -2.86 units on a scale | Standard Error 0.39 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 1 | -0.71 units on a scale | Standard Error 0.27 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 2 | -1.22 units on a scale | Standard Error 0.31 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 3 | -1.83 units on a scale | Standard Error 0.3 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 11 | -2.98 units on a scale | Standard Error 0.39 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 4 | -2.35 units on a scale | Standard Error 0.35 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 5 | -2.65 units on a scale | Standard Error 0.37 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 6 | -2.64 units on a scale | Standard Error 0.38 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 2 | -0.99 units on a scale | Standard Error 0.19 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 3 | -1.32 units on a scale | Standard Error 0.2 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 12 | -3.08 units on a scale | Standard Error 0.4 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 4 | -1.61 units on a scale | Standard Error 0.22 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 7 | -2.73 units on a scale | Standard Error 0.38 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 5 | -1.95 units on a scale | Standard Error 0.23 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 6 | -2.03 units on a scale | Standard Error 0.23 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 7 | -2.14 units on a scale | Standard Error 0.23 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 8 | -2.78 units on a scale | Standard Error 0.39 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 8 | -2.16 units on a scale | Standard Error 0.24 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 9 | -2.38 units on a scale | Standard Error 0.24 |
| Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 1 | -0.48 units on a scale | Standard Error 0.16 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 8 | -2.31 units on a scale | Standard Error 0.23 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 6 | -1.98 units on a scale | Standard Error 0.23 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 2 | -1.28 units on a scale | Standard Error 0.19 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 11 | -2.41 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 9 | -2.10 units on a scale | Standard Error 0.35 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 6 | -1.88 units on a scale | Standard Error 0.34 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 12 | -2.53 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 12 | -2.10 units on a scale | Standard Error 0.36 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 3 | -1.68 units on a scale | Standard Error 0.21 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, baseline | 5.49 units on a scale | Standard Error 1.45 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 8 | -2.06 units on a scale | Standard Error 0.35 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 7 | -2.17 units on a scale | Standard Error 0.23 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 1 | -0.38 units on a scale | Standard Error 0.25 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 10 | -1.92 units on a scale | Standard Error 0.35 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 4 | -1.75 units on a scale | Standard Error 0.22 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 2 | -1.10 units on a scale | Standard Error 0.28 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, baseline | 5.92 units on a scale | Standard Error 1.48 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 10 | -2.44 units on a scale | Standard Error 0.24 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 3 | -1.62 units on a scale | Standard Error 0.3 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 9 | -2.37 units on a scale | Standard Error 0.23 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 5 | -1.96 units on a scale | Standard Error 0.22 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 4 | -1.67 units on a scale | Standard Error 0.32 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 11 | -2.09 units on a scale | Standard Error 0.35 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 7 | -2.07 units on a scale | Standard Error 0.34 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | de novo, week 5 | -1.81 units on a scale | Standard Error 0.33 |
| Gabapentin + Duloxetine | Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) | prior use, week 1 | -0.65 units on a scale | Standard Error 0.17 |
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.p-value: 0.62295% CI: [-0.48, 0.8]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.p-value: 0.15395% CI: [-0.18, 1.16]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.p-value: 0.34495% CI: [-0.35, 1]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.p-value: 0.05895% CI: [-0.02, 1.45]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.p-value: 0.03295% CI: [0.07, 1.59]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.p-value: 0.76295% CI: [-0.66, 0.9]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.p-value: 0.02995% CI: [0.09, 1.73]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.p-value: 0.0195% CI: [0.27, 1.97]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.p-value: 0.61995% CI: [-0.63, 1.06]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.p-value: 0.05895% CI: [-0.03, 1.69]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.p-value: 0.00195% CI: [0.61, 2.41]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.p-value: 0.14295% CI: [-0.23, 1.58]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.p-value: 0.06595% CI: [-0.05, 1.76]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.p-value: <0.00195% CI: [0.75, 2.65]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.p-value: 0.07995% CI: [-0.1, 1.79]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.p-value: 0.09395% CI: [-0.13, 1.71]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.p-value: 0.00295% CI: [0.59, 2.53]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.p-value: 0.11995% CI: [-0.2, 1.74]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.p-value: 0.03695% CI: [0.06, 1.91]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.p-value: <0.00195% CI: [0.68, 2.61]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.p-value: 0.17895% CI: [-0.3, 1.63]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.p-value: 0.09395% CI: [-0.14, 1.75]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.p-value: 0.00395% CI: [0.53, 2.51]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.p-value: 0.15795% CI: [-0.28, 1.71]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.p-value: 0.06395% CI: [-0.05, 1.82]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.p-value: <0.00195% CI: [0.7, 2.66]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.p-value: 0.11495% CI: [-0.19, 1.77]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.p-value: 0.29595% CI: [-0.44, 1.46]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.p-value: 0.00595% CI: [0.45, 2.44]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.p-value: 0.06695% CI: [-0.06, 1.94]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.p-value: 0.20895% CI: [-0.35, 1.58]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.p-value: 0.00495% CI: [0.49, 2.51]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.p-value: 0.08695% CI: [-0.13, 1.89]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.p-value: 0.32895% CI: [-0.49, 1.45]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.p-value: 0.00595% CI: [0.44, 2.47]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.p-value: 0.05995% CI: [-0.04, 1.99]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.p-value: 0.11795% CI: [-0.09, 0.79]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.p-value: 0.41295% CI: [-0.25, 0.62]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.p-value: 0.44595% CI: [-0.6, 0.26]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.p-value: 0.02595% CI: [0.07, 1.09]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.p-value: 0.25795% CI: [-0.21, 0.79]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.p-value: 0.25795% CI: [-0.79, 0.21]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.p-value: 0.07595% CI: [-0.05, 1.04]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.p-value: 0.63495% CI: [-0.42, 0.68]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.p-value: 0.19395% CI: [-0.91, 0.19]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.p-value: 0.68895% CI: [-0.46, 0.7]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.p-value: 0.94495% CI: [-0.6, 0.56]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.p-value: 0.6495% CI: [-0.73, 0.45]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.p-value: 0.43995% CI: [-0.37, 0.84]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.p-value: 0.46195% CI: [-0.38, 0.84]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.p-value: 0.97695% CI: [-0.62, 0.6]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.p-value: 0.82995% CI: [-0.55, 0.68]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.p-value: 0.71395% CI: [-0.5, 0.74]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.p-value: 0.87895% CI: [-0.58, 0.67]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.p-value: 0.44795% CI: [-0.38, 0.85]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.p-value: 0.51195% CI: [-0.41, 0.83]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.p-value: 0.92495% CI: [-0.65, 0.59]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.p-value: 0.18595% CI: [-0.2, 1.06]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.p-value: 0.40395% CI: [-0.37, 0.91]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.p-value: 0.63695% CI: [-0.79, 0.49]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.p-value: 0.30495% CI: [-0.3, 0.95]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.p-value: 0.29595% CI: [-0.29, 0.97]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.p-value: 0.97595% CI: [-0.62, 0.64]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.p-value: 0.34995% CI: [-0.33, 0.93]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.p-value: 0.35195% CI: [-0.34, 0.94]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.p-value: 0.99295% CI: [-0.64, 0.65]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.p-value: 0.68195% CI: [-0.5, 0.77]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.p-value: 0.56995% CI: [-0.46, 0.83]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.p-value: 0.87195% CI: [-0.6, 0.7]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.p-value: 0.67595% CI: [-0.5, 0.78]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.p-value: 0.82395% CI: [-0.57, 0.72]Mixed Models Analysis
Comparison: Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.p-value: 0.8595% CI: [-0.72, 0.59]Mixed Models Analysis
Secondary
Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. It was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible.
Time frame: baseline, 12 weeks
Population: All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.