Diabetic Neuropathies
Conditions
Brief summary
To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.
Interventions
DRUGDuloxetine Hydrochloride
60 mg every day (QD) (morning or evening), by mouth (PO)
DRUGPlacebo
Placebo every day (QD), by mouth (PO)
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months. * May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study. * Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
Exclusion criteria
* Glycosylated hemoglobin (A1C) \> 12% * Severe hepatic disease * History of substance abuse or dependence within the past year, excluding nicotine and caffeine. * Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study. * Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study. * Treatment of fluoxetine within 30 days of starting the study. * Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score | Baseline and 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity | Baseline and 12 weeks | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. |
| Time Course of Change in Patient Global Impression - Improvement Scale | baseline, over 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). |
| Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) | Baseline and 12 weeks | The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. |
| Number of Participants Discontinuing Due to Adverse Events | over 12 weeks | — |
| Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | over 12 weeks | Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events. |
| Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Baseline and 12 weeks | Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10). |
| Vital Signs - Weight | Baseline and 12 weeks | Change from baseline to endpoint in body weight. |
| Vital Signs - Pulse Rate | Baseline and 12 weeks | Change from baseline to endpoint in pulse rate. |
| Vital Signs - Blood Pressure | Baseline and 12 weeks | Change from baseline to endpoint in systolic and diastolic blood pressure. |
| Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Baseline and 12 weeks | Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides. |
| Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Baseline and 12 weeks | Significantly different laboratory values between the two groups in baseline to endpoint changes |
| Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | Baseline and 12 weeks | Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine 60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response) | 106 |
| Placebo Placebo every day (QD), by mouth (PO) for 12 weeks | 109 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 4 |
| Overall Study | Lack of Efficacy | 1 | 4 |
| Overall Study | Protocol Violation | 1 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Duloxetine | Placebo | Total |
|---|---|---|---|
| Age Continuous | 58.59 years STANDARD_DEVIATION 10.37 | 59.90 years STANDARD_DEVIATION 9.52 | 59.25 years STANDARD_DEVIATION 9.94 |
| Beck Depression Inventory-II Total Score | 15.97 units on a scale STANDARD_DEVIATION 10.66 | 15.27 units on a scale STANDARD_DEVIATION 11.49 | 15.61 units on a scale STANDARD_DEVIATION 11.07 |
| Brief Pain Inventory 24-Hour Average Pain Score | 5.47 units on a scale STANDARD_DEVIATION 1.31 | 5.52 units on a scale STANDARD_DEVIATION 1.39 | 5.50 units on a scale STANDARD_DEVIATION 1.35 |
| Clinical Global Impressions of Severity Score | 4.26 units on a scale STANDARD_DEVIATION 0.76 | 4.38 units on a scale STANDARD_DEVIATION 0.91 | 4.32 units on a scale STANDARD_DEVIATION 0.84 |
| Diabetic Neuropathy History Duration of Diabetes | 9.07 years STANDARD_DEVIATION 6.32 | 10.21 years STANDARD_DEVIATION 6.91 | 9.65 years STANDARD_DEVIATION 6.63 |
| Diabetic Neuropathy History Duration of Diabetic Neuropathy | 2.13 years STANDARD_DEVIATION 2.6 | 2.50 years STANDARD_DEVIATION 2.98 | 2.32 years STANDARD_DEVIATION 2.8 |
| Diabetic Neuropathy History Duration of Diabetic Peripheral Neuropathic Pain | 3.09 years STANDARD_DEVIATION 3.11 | 3.34 years STANDARD_DEVIATION 3.36 | 3.22 years STANDARD_DEVIATION 3.24 |
| Height | 162.64 centimeters STANDARD_DEVIATION 7.72 | 162.12 centimeters STANDARD_DEVIATION 7.96 | 162.37 centimeters STANDARD_DEVIATION 7.83 |
| Major Depressive Disorder No | 89 participants | 88 participants | 177 participants |
| Major Depressive Disorder Yes | 17 participants | 21 participants | 38 participants |
| Michigan Neuropathy Screening Instrument | 4.45 units on a scale STANDARD_DEVIATION 1.19 | 4.59 units on a scale STANDARD_DEVIATION 1.19 | 4.52 units on a scale STANDARD_DEVIATION 1.19 |
| Race/Ethnicity East Asian | 106 participants | 109 participants | 215 participants |
| Region of Enrollment China | 106 participants | 109 participants | 215 participants |
| Sex: Female, Male Female | 55 Participants | 59 Participants | 114 Participants |
| Sex: Female, Male Male | 51 Participants | 50 Participants | 101 Participants |
| Type of Diabetes Mellitus Type I Diabetes Mellitus | 3 participants | 2 participants | 5 participants |
| Type of Diabetes Mellitus Type II Diabetes Mellitus | 103 participants | 107 participants | 210 participants |
| Weight | 64.06 kilograms STANDARD_DEVIATION 10.62 | 63.25 kilograms STANDARD_DEVIATION 11.52 | 63.65 kilograms STANDARD_DEVIATION 11.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 77 / — | 85 / — |
| serious Total, serious adverse events | 2 / — | 2 / — |
Outcome results
Primary
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
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).
Time frame: Baseline and 12 weeks
Population: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score | -2.69 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score | -2.31 units on a scale | Standard Error 0.18 |
Comparison: With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.p-value: 0.617ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.
Time frame: Baseline and 12 weeks
Population: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | 5-Item Score | -2.27 units on a scale | Standard Error 0.31 |
| Duloxetine | Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | 8-Item Score | -3.58 units on a scale | Standard Error 0.47 |
| Placebo | Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | 5-Item Score | -1.97 units on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | 8-Item Score | -3.31 units on a scale | Standard Error 0.45 |
p-value: 0.364ANCOVA
p-value: 0.59ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).
Time frame: Baseline and 12 weeks
Population: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Worst Pain Score | -3.48 units on a scale | Standard Error 0.27 |
| Duloxetine | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Least Pain Score | -1.69 units on a scale | Standard Error 0.2 |
| Duloxetine | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Pain Right Now Score | -2.72 units on a scale | Standard Error 0.26 |
| Duloxetine | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Average Interference Score | -2.28 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Average Interference Score | -1.88 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Worst Pain Score | -2.93 units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Pain Right Now Score | -1.99 units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Least Pain Score | -1.37 units on a scale | Standard Error 0.2 |
p-value: 0.07ANCOVA
p-value: 0.151ANCOVA
p-value: 0.012ANCOVA
p-value: 0.077ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Time frame: Baseline and 12 weeks
Population: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity | -1.24 units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity | -0.99 units on a scale | Standard Error 0.11 |
p-value: 0.036ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.
Time frame: Baseline and 12 weeks
Population: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) | 0.12 units on a scale | Standard Error 0.02 |
| Placebo | Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) | 0.10 units on a scale | Standard Error 0.02 |
p-value: 0.207ANCOVA
Secondary
Number of Participants Discontinuing Due to Adverse Events
Time frame: over 12 weeks
Population: Intention to Treat Analysis. All randomized patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Participants Discontinuing Due to Adverse Events | 15 participants |
| Placebo | Number of Participants Discontinuing Due to Adverse Events | 4 participants |
p-value: 0.008Fisher Exact
Secondary
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.
Time frame: over 12 weeks
Population: Number of randomized patients in each treatment arm for each dosing group
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pruritus | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pain | 1 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Headache | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Arthralgia | 1 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hyperhidrosis | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Nausea | 14 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypersomnia | 0 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypoglycaemia | 5 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Lethargy | 6 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Insomnia | 3 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Asthenia | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Therapeutic response unexpected | 6 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Chest discomfort | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Vomiting | 3 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Constipation | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal pain upper | 0 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Stomach discomfort | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Cough | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Decreased appetite | 0 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Somnolence | 9 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Diarrhoea | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dizziness | 5 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Anorexia | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal discomfort | 3 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dry mouth | 2 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dyslipidaemia | 1 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal distension | 7 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Palpitations | 7 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dysuria | 5 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Thirst | 4 participants |
| Duloxetine | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Fatigue | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dysuria | 4 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Fatigue | 5 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Cough | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Headache | 2 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal pain upper | 4 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Nausea | 18 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Somnolence | 8 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hyperhidrosis | 5 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Arthralgia | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dry mouth | 4 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Decreased appetite | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypersomnia | 2 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal distension | 2 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Lethargy | 5 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Vomiting | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypoglycaemia | 5 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Therapeutic response unexpected | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Anorexia | 7 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Palpitations | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Insomnia | 2 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Diarrhoea | 6 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Asthenia | 4 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal discomfort | 1 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Thirst | 1 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pruritus | 1 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Chest discomfort | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pain | 1 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Stomach discomfort | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dizziness | 11 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Constipation | 7 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dyslipidaemia | 3 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Fatigue | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal discomfort | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal distension | 4 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal pain upper | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Anorexia | 1 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Arthralgia | 3 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Asthenia | 0 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Chest discomfort | 1 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Constipation | 5 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Cough | 4 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Decreased appetite | 0 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Diarrhoea | 5 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dizziness | 9 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dry mouth | 1 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dyslipidaemia | 1 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dysuria | 0 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Headache | 4 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hyperhidrosis | 1 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypersomnia | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypoglycaemia | 3 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Insomnia | 3 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Lethargy | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Nausea | 8 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pain | 3 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Palpitations | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pruritus | 4 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Somnolence | 2 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Stomach discomfort | 5 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Therapeutic response unexpected | 6 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Thirst | 0 participants |
| Placebo - Morning Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Vomiting | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dysuria | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Anorexia | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pain | 0 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dyslipidaemia | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dry mouth | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal pain upper | 0 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Palpitations | 3 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Dizziness | 3 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Diarrhoea | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Vomiting | 3 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Pruritus | 4 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Decreased appetite | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Cough | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Thirst | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Somnolence | 4 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Constipation | 4 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Chest discomfort | 0 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal distension | 3 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Stomach discomfort | 0 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Asthenia | 1 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Arthralgia | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Insomnia | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypoglycaemia | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hypersomnia | 3 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Abdominal discomfort | 4 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Lethargy | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Hyperhidrosis | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Headache | 2 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Therapeutic response unexpected | 6 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Nausea | 5 participants |
| Placebo - Evening Dosing | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Fatigue | 6 participants |
Secondary
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.
Time frame: Baseline and 12 weeks
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Chloride Baseline | 102.94 millimole/Liter | Standard Deviation 3.07 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Chloride Change to Endpoint | -1.15 millimole/Liter | Standard Deviation 3.6 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | High Density Lipoprotein Cholesterol Baseline | 1.30 millimole/Liter | Standard Deviation 0.37 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | High Density Lipoprotein Change to Endpoint | 0.03 millimole/Liter | Standard Deviation 0.22 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Sodium Baseline | 143.03 millimole/Liter | Standard Deviation 2.83 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Sodium Change to Endpoint | -1.25 millimole/Liter | Standard Deviation 3.64 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Triglycerides Baseline | 1.76 millimole/Liter | Standard Deviation 1.48 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Triglycerides Change to Endpoint | -0.05 millimole/Liter | Standard Deviation 1.07 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Triglycerides Change to Endpoint | 0.26 millimole/Liter | Standard Deviation 1 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Chloride Baseline | 102.87 millimole/Liter | Standard Deviation 2.99 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Sodium Baseline | 142.76 millimole/Liter | Standard Deviation 3 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Chloride Change to Endpoint | -0.20 millimole/Liter | Standard Deviation 2.81 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Triglycerides Baseline | 1.40 millimole/Liter | Standard Deviation 0.76 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | High Density Lipoprotein Cholesterol Baseline | 1.33 millimole/Liter | Standard Deviation 0.33 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Sodium Change to Endpoint | -0.19 millimole/Liter | Standard Deviation 2.72 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | High Density Lipoprotein Change to Endpoint | -0.04 millimole/Liter | Standard Deviation 0.19 |
p-value: 0.014ANOVA
p-value: 0.005ANOVA
p-value: 0.011ANOVA
p-value: 0.044ANOVA
Secondary
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid
Significantly different laboratory values between the two groups in baseline to endpoint changes
Time frame: Baseline and 12 weeks
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Uric Acid Baseline | 293.24 micromole/Liter | Standard Deviation 72.51 |
| Duloxetine | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Uric Acid Change to Endpoint | -7.46 micromole/Liter | Standard Deviation 62.19 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Uric Acid Baseline | 283.98 micromole/Liter | Standard Deviation 75.88 |
| Placebo | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Uric Acid Change to Endpoint | 2.49 micromole/Liter | Standard Deviation 53.29 |
p-value: 0.017ANOVA
Secondary
Time Course of Change in Patient Global Impression - Improvement Scale
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: baseline, over 12 weeks
Population: Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Time Course of Change in Patient Global Impression - Improvement Scale | Week 2 (N=98, N=107) | 2.91 units on a scale | Standard Error 0.09 |
| Duloxetine | Time Course of Change in Patient Global Impression - Improvement Scale | Week 8 (N=91, N=95) | 2.29 units on a scale | Standard Error 0.11 |
| Duloxetine | Time Course of Change in Patient Global Impression - Improvement Scale | Week 4 (N=94, N=101) | 2.57 units on a scale | Standard Error 0.1 |
| Duloxetine | Time Course of Change in Patient Global Impression - Improvement Scale | Week 12 (N=87, N=92) | 2.27 units on a scale | Standard Error 0.11 |
| Duloxetine | Time Course of Change in Patient Global Impression - Improvement Scale | Week 1 (N=5, N=2) | 3.45 units on a scale | Standard Error 0.56 |
| Placebo | Time Course of Change in Patient Global Impression - Improvement Scale | Week 12 (N=87, N=92) | 2.58 units on a scale | Standard Error 0.11 |
| Placebo | Time Course of Change in Patient Global Impression - Improvement Scale | Week 1 (N=5, N=2) | 3.51 units on a scale | Standard Error 0.88 |
| Placebo | Time Course of Change in Patient Global Impression - Improvement Scale | Week 2 (N=98, N=107) | 3.23 units on a scale | Standard Error 0.09 |
| Placebo | Time Course of Change in Patient Global Impression - Improvement Scale | Week 4 (N=94, N=101) | 2.83 units on a scale | Standard Error 0.1 |
| Placebo | Time Course of Change in Patient Global Impression - Improvement Scale | Week 8 (N=91, N=95) | 2.76 units on a scale | Standard Error 0.11 |
p-value: 0.955Mixed Models Analysis
p-value: 0.004Mixed Models Analysis
p-value: 0.037Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.028Mixed Models Analysis
Secondary
Vital Signs - Blood Pressure
Change from baseline to endpoint in systolic and diastolic blood pressure.
Time frame: Baseline and 12 weeks
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Vital Signs - Blood Pressure | Systolic Blood Pressure | -0.48 mm Hg | Standard Error 1.61 |
| Duloxetine | Vital Signs - Blood Pressure | Diastolic Blood Pressure | 0.45 mm Hg | Standard Error 0.95 |
| Placebo | Vital Signs - Blood Pressure | Systolic Blood Pressure | -1.47 mm Hg | Standard Error 1.56 |
| Placebo | Vital Signs - Blood Pressure | Diastolic Blood Pressure | -0.21 mm Hg | Standard Error 0.92 |
p-value: 0.642ANOVA
p-value: 0.601ANOVA
Secondary
Vital Signs - Pulse Rate
Change from baseline to endpoint in pulse rate.
Time frame: Baseline and 12 weeks
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Vital Signs - Pulse Rate | 1.71 beats per minute | Standard Error 1.06 |
| Placebo | Vital Signs - Pulse Rate | 0.32 beats per minute | Standard Error 1.03 |
p-value: 0.324ANOVA
Secondary
Vital Signs - Weight
Change from baseline to endpoint in body weight.
Time frame: Baseline and 12 weeks
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Vital Signs - Weight | -0.17 kilograms | Standard Error 0.21 |
| Placebo | Vital Signs - Weight | -0.03 kilograms | Standard Error 0.21 |
p-value: 0.62ANOVA