Diabetic Neuropathy, Painful
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)
Interventions
DRUGPF-05089771 150 mg
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
DRUGMatched placebo for PF-05089771 150 mg and pregabalin 300 mg
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
DRUGPF-05089771 150 mg + Pregabalin 300 mg
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18 years to 80 years. * Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization. * Presence of ongoing pain due to DPN for at least 6 months. * Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.
Exclusion criteria
* Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study. * Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy. * Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities. * Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Pain Numeric Rating Scale (NRS) | Baseline, Week 1, Week 2, Week 3 and Week 4 | The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Baseline, Week 1, Week 2, Week 3, and Week 4 | Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary). |
| Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Baseline, Week 2, and Week 4 | Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. |
| Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Baseline, Week 2 and Week 4 | Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. |
| Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline, Week 2, and Week 4 | Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. |
| Total Amount of Rescue Medication Per Week | Baseline, Week 1, Week 2, Week 3, and Week 4 | Total amount of rescue medication participants take per week |
| Number of Days Participants Take Rescue Medication | Baseline, Week 1, Week 2, Week 3 and Week 4 | Number of days participants take rescue medication per week. |
| Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline, Week 2 and Week 4 | Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. |
| Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Baseline, Week 2 and Week 4 | Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. |
| Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Baseline, Week 1, Week 2, Week 3 and Week 4 | Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary). |
| Patient's Global Impression of Change Score (PGIC). | Baseline, Week 2, and Week 4 | Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, Improved, No Change and Worse. |
| Daily Sleep Interference Scale Score (DSIS). | Baseline, Week 1, Week 2, Week 3 and Week 4 | Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Screening to Day 36, and Day 64 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Screening, Day 1, Day 15 and Day 29 | The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests. |
| Fasted Total Cholesterol Values | Baseline, Week 2 and Week 4 | Percentage Change from Baseline in Fasted Total Cholesterol values |
| Fasted Low Density Lipoprotein (LDL) Cholesterol | Baseline, Week 2 and Week 4 | Percentage Change from Baseline in LDL cholesterol Friedewald by PEG |
| Plasma Concentration of PF-05089771 | Baseline, Week 2 and Week 4 | All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed. |
| Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Baseline, Week 2 and Week 4 | Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. |
Countries
United States
Participant flow
Recruitment details
Eligibility included healthy male and/or female participants of non childbearing potential between the ages of 18 and 80 years, inclusive, and a diagnosis of painful diabetic peripheral neuropathy and type II diabetes. Following the interim analysis, the study was stopped. No participants were dosed with PF-05089771 150mg BID + pregabalin.
Pre-assignment details
A number of 141 participants were the anticipated to be enrolled based on a discontinuation rate calculated from previous Pfizer DPN studies. The study discontinuation rate was lower than anticipated, hence fewer participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| PF-05089771 150 mg BID Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks. | 44 |
| Pregabalin Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks. | 46 |
| Placebo Participants received matched placebo oral capsule for 4 weeks. | 45 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 | 2 |
| Overall Study | Does not Meet Entrance Criteria | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Other | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | PF-05089771 150 mg BID | Pregabalin | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 9.4 | 58.1 years STANDARD_DEVIATION 11.3 | 59.2 years STANDARD_DEVIATION 10.9 | 58.9 years STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 14 Participants | 50 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 31 Participants | 85 Participants |
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 | 3 / 44 | 12 / 46 | 10 / 45 |
| serious Total, serious adverse events | 1 / 44 | 1 / 46 | 0 / 45 |
Outcome results
Primary
Daily Pain Numeric Rating Scale (NRS)
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
Time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Daily Pain Numeric Rating Scale (NRS) | Week 4 (n = 41, 38, 39) | 4.83 Unit on a scale | Standard Deviation 1.595 |
| PF-05089771 150 mg BID | Daily Pain Numeric Rating Scale (NRS) | Week 2 (n = 43, 44, 40) | 5.14 Unit on a scale | Standard Deviation 1.762 |
| PF-05089771 150 mg BID | Daily Pain Numeric Rating Scale (NRS) | Week 3 (n = 38, 40, 41) | 5.01 Unit on a scale | Standard Deviation 1.82 |
| PF-05089771 150 mg BID | Daily Pain Numeric Rating Scale (NRS) | Baseline (n = 44, 46, 45) | 6.17 Unit on a scale | Standard Deviation 1.164 |
| PF-05089771 150 mg BID | Daily Pain Numeric Rating Scale (NRS) | Week 1 (n = 44, 46, 44) | 5.45 Unit on a scale | Standard Deviation 1.372 |
| Pregabalin | Daily Pain Numeric Rating Scale (NRS) | Baseline (n = 44, 46, 45) | 6.62 Unit on a scale | Standard Deviation 1.42 |
| Pregabalin | Daily Pain Numeric Rating Scale (NRS) | Week 1 (n = 44, 46, 44) | 5.87 Unit on a scale | Standard Deviation 1.872 |
| Pregabalin | Daily Pain Numeric Rating Scale (NRS) | Week 2 (n = 43, 44, 40) | 5.26 Unit on a scale | Standard Deviation 2.302 |
| Pregabalin | Daily Pain Numeric Rating Scale (NRS) | Week 3 (n = 38, 40, 41) | 5.36 Unit on a scale | Standard Deviation 2.386 |
| Pregabalin | Daily Pain Numeric Rating Scale (NRS) | Week 4 (n = 41, 38, 39) | 5.14 Unit on a scale | Standard Deviation 2.508 |
| Placebo | Daily Pain Numeric Rating Scale (NRS) | Week 4 (n = 41, 38, 39) | 5.61 Unit on a scale | Standard Deviation 1.82 |
| Placebo | Daily Pain Numeric Rating Scale (NRS) | Week 3 (n = 38, 40, 41) | 5.76 Unit on a scale | Standard Deviation 1.54 |
| Placebo | Daily Pain Numeric Rating Scale (NRS) | Week 1 (n = 44, 46, 44) | 6.07 Unit on a scale | Standard Deviation 1.454 |
| Placebo | Daily Pain Numeric Rating Scale (NRS) | Baseline (n = 44, 46, 45) | 6.35 Unit on a scale | Standard Deviation 1.17 |
| Placebo | Daily Pain Numeric Rating Scale (NRS) | Week 2 (n = 43, 44, 40) | 6.10 Unit on a scale | Standard Deviation 1.504 |
Comparison: Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.90% CI: [-1, 0.17]
Comparison: Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.90% CI: [-0.91, -0.2]
Secondary
Daily Sleep Interference Scale Score (DSIS).
Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
Time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Daily Sleep Interference Scale Score (DSIS). | Week 4 (n = 41, 38, 39) | 3.4 number on a scale | Standard Deviation 2.13 |
| PF-05089771 150 mg BID | Daily Sleep Interference Scale Score (DSIS). | Week 2 (n = 43, 44, 40) | 4.0 number on a scale | Standard Deviation 2.33 |
| PF-05089771 150 mg BID | Daily Sleep Interference Scale Score (DSIS). | Week 3 (n = 38, 40, 41) | 3.6 number on a scale | Standard Deviation 2.28 |
| PF-05089771 150 mg BID | Daily Sleep Interference Scale Score (DSIS). | Week 1 (n= 44, 46, 44) | 4.1 number on a scale | Standard Deviation 2.29 |
| PF-05089771 150 mg BID | Daily Sleep Interference Scale Score (DSIS). | Baseline (n = 44, 46, 45) | 4.7 number on a scale | Standard Deviation 2.42 |
| Pregabalin | Daily Sleep Interference Scale Score (DSIS). | Week 4 (n = 41, 38, 39) | 4.2 number on a scale | Standard Deviation 2.82 |
| Pregabalin | Daily Sleep Interference Scale Score (DSIS). | Baseline (n = 44, 46, 45) | 5.6 number on a scale | Standard Deviation 2.38 |
| Pregabalin | Daily Sleep Interference Scale Score (DSIS). | Week 1 (n= 44, 46, 44) | 4.7 number on a scale | Standard Deviation 2.55 |
| Pregabalin | Daily Sleep Interference Scale Score (DSIS). | Week 2 (n = 43, 44, 40) | 4.1 number on a scale | Standard Deviation 2.74 |
| Pregabalin | Daily Sleep Interference Scale Score (DSIS). | Week 3 (n = 38, 40, 41) | 4.4 number on a scale | Standard Deviation 2.71 |
| Placebo | Daily Sleep Interference Scale Score (DSIS). | Week 4 (n = 41, 38, 39) | 4.3 number on a scale | Standard Deviation 2.51 |
| Placebo | Daily Sleep Interference Scale Score (DSIS). | Baseline (n = 44, 46, 45) | 4.9 number on a scale | Standard Deviation 2.29 |
| Placebo | Daily Sleep Interference Scale Score (DSIS). | Week 3 (n = 38, 40, 41) | 4.3 number on a scale | Standard Deviation 2.49 |
| Placebo | Daily Sleep Interference Scale Score (DSIS). | Week 1 (n= 44, 46, 44) | 4.7 number on a scale | Standard Deviation 2.46 |
| Placebo | Daily Sleep Interference Scale Score (DSIS). | Week 2 (n = 43, 44, 40) | 4.7 number on a scale | Standard Deviation 2.41 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1.16, -0.02]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1.57, -0.43]
Secondary
Fasted Low Density Lipoprotein (LDL) Cholesterol
Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
Time frame: Baseline, Week 2 and Week 4
Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Fasted Low Density Lipoprotein (LDL) Cholesterol | Week 2 (n = 38, 34, 39) | 8.17 Perecent change | Standard Deviation 23.849 |
| PF-05089771 150 mg BID | Fasted Low Density Lipoprotein (LDL) Cholesterol | Week 4 (n = 37, 31, 36) | 13.61 Perecent change | Standard Deviation 29.729 |
| Pregabalin | Fasted Low Density Lipoprotein (LDL) Cholesterol | Week 2 (n = 38, 34, 39) | -1.73 Perecent change | Standard Deviation 14.496 |
| Pregabalin | Fasted Low Density Lipoprotein (LDL) Cholesterol | Week 4 (n = 37, 31, 36) | 0.85 Perecent change | Standard Deviation 13.512 |
| Placebo | Fasted Low Density Lipoprotein (LDL) Cholesterol | Week 2 (n = 38, 34, 39) | 0.81 Perecent change | Standard Deviation 22.9 |
| Placebo | Fasted Low Density Lipoprotein (LDL) Cholesterol | Week 4 (n = 37, 31, 36) | 1.48 Perecent change | Standard Deviation 19.804 |
Comparison: Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.90% CI: [2.94, 20.17]
Comparison: Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.90% CI: [-11.38, 6.54]
Secondary
Fasted Total Cholesterol Values
Percentage Change from Baseline in Fasted Total Cholesterol values
Time frame: Baseline, Week 2 and Week 4
Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Fasted Total Cholesterol Values | Week 4 (n = 40, 33, 39) | 6.59 Percent change | Standard Deviation 15.618 |
| PF-05089771 150 mg BID | Fasted Total Cholesterol Values | Week 2 (n = 41, 37, 41) | 3.46 Percent change | Standard Deviation 12.279 |
| Pregabalin | Fasted Total Cholesterol Values | Week 4 (n = 40, 33, 39) | -0.11 Percent change | Standard Deviation 10.023 |
| Pregabalin | Fasted Total Cholesterol Values | Week 2 (n = 41, 37, 41) | -1.45 Percent change | Standard Deviation 10.242 |
| Placebo | Fasted Total Cholesterol Values | Week 4 (n = 40, 33, 39) | -1.71 Percent change | Standard Deviation 14.242 |
| Placebo | Fasted Total Cholesterol Values | Week 2 (n = 41, 37, 41) | -0.43 Percent change | Standard Deviation 14.271 |
Comparison: Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.90% CI: [2.98, 13.01]
Comparison: Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.90% CI: [-4.46, 5.95]
Secondary
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 2, and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Baseline (n = 44, 46, 45) | 4.6 Unit on a scale | Standard Deviation 2.71 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Week 2 (n = 42, 41, 43) | 3.7 Unit on a scale | Standard Deviation 2.94 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Week 4 (n = 42, 38, 42) | 3.4 Unit on a scale | Standard Deviation 3.04 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Week 4 (n = 42, 38, 42) | 4.3 Unit on a scale | Standard Deviation 2.8 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Week 2 (n = 42, 41, 43) | 4.3 Unit on a scale | Standard Deviation 3.06 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Baseline (n = 44, 46, 45) | 5.3 Unit on a scale | Standard Deviation 2.49 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Baseline (n = 44, 46, 45) | 4.8 Unit on a scale | Standard Deviation 2.35 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Week 4 (n = 42, 38, 42) | 4.5 Unit on a scale | Standard Deviation 2.55 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain | Week 2 (n = 42, 41, 43) | 4.2 Unit on a scale | Standard Deviation 2.35 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1.75, -0.32]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 490% CI: [-1.43, 0.04]
Secondary
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 2 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Week 4 (n = 42, 37, 42) | 2.3 Unit on a scale | Standard Deviation 2.24 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline (n = 44, 45, 45) | 2.7 Unit on a scale | Standard Deviation 2.38 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Week 2 (n = 42, 40, 43) | 2.0 Unit on a scale | Standard Deviation 1.92 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Week 4 (n = 42, 37, 42) | 3.8 Unit on a scale | Standard Deviation 3.07 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline (n = 44, 45, 45) | 5.0 Unit on a scale | Standard Deviation 2.51 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Week 2 (n = 42, 40, 43) | 4.0 Unit on a scale | Standard Deviation 2.67 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Week 4 (n = 42, 37, 42) | 3.6 Unit on a scale | Standard Deviation 2.53 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline (n = 44, 45, 45) | 4.2 Unit on a scale | Standard Deviation 2.42 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Week 2 (n = 42, 40, 43) | 3.5 Unit on a scale | Standard Deviation 2.47 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-0.49, 0.67]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1.05, 0.13]
Secondary
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 2 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Week 2 (n = 42, 41, 43) | 4.8 Unit on a scale | Standard Deviation 2.45 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Baseline (n = 44, 46, 45) | 5.7 Unit on a scale | Standard Deviation 2.02 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Week 4 (n = 42, 38, 42) | 4.9 Unit on a scale | Standard Deviation 2.34 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Week 2 (n = 42, 41, 43) | 5.3 Unit on a scale | Standard Deviation 2.83 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Baseline (n = 44, 46, 45) | 6.1 Unit on a scale | Standard Deviation 2.35 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Week 4 (n = 42, 38, 42) | 5.4 Unit on a scale | Standard Deviation 2.84 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Baseline (n = 44, 46, 45) | 6.6 Unit on a scale | Standard Deviation 1.96 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Week 4 (n = 42, 38, 42) | 5.9 Unit on a scale | Standard Deviation 2.63 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia | Week 2 (n = 42, 41, 43) | 5.9 Unit on a scale | Standard Deviation 2.4 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1.09, 0.39]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1, 0.51]
Secondary
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 2, and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Week 4 (n = 42, 38, 42） | 3.9 Unit on a scale | Standard Deviation 2.87 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline (n = 44, 46, 45) | 4.5 Unit on a scale | Standard Deviation 2.36 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Week 2 (n = 42, 41, 43) | 4.1 Unit on a scale | Standard Deviation 2.61 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline (n = 44, 46, 45) | 5.8 Unit on a scale | Standard Deviation 2.18 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Week 2 (n = 42, 41, 43) | 4.7 Unit on a scale | Standard Deviation 2.98 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Week 4 (n = 42, 38, 42） | 4.6 Unit on a scale | Standard Deviation 2.83 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Week 4 (n = 42, 38, 42） | 4.8 Unit on a scale | Standard Deviation 2.55 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Week 2 (n = 42, 41, 43) | 4.9 Unit on a scale | Standard Deviation 2.11 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline (n = 44, 46, 45) | 5.6 Unit on a scale | Standard Deviation 2.23 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-0.87, 0.67]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1.36, 0.2]
Secondary
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 2 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Week 4 (n = 42, 38, 42) | 3.4 Unit on a scale | Standard Deviation 2.67 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Week 2 (n = 42, 41, 43) | 3.3 Unit on a scale | Standard Deviation 2.51 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Baseline (n = 44, 46, 45) | 3.8 Unit on a scale | Standard Deviation 2.48 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Week 4 (n = 42, 38, 42) | 3.9 Unit on a scale | Standard Deviation 3.08 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Baseline (n = 44, 46, 45) | 4.9 Unit on a scale | Standard Deviation 2.21 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Week 2 (n = 42, 41, 43) | 4.4 Unit on a scale | Standard Deviation 2.83 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Week 4 (n = 42, 38, 42) | 4.0 Unit on a scale | Standard Deviation 2.48 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Week 2 (n = 42, 41, 43) | 4.2 Unit on a scale | Standard Deviation 2.33 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain | Baseline (n = 44, 46, 45) | 4.5 Unit on a scale | Standard Deviation 2.4 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 490% CI: [-0.86, 0.43]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 490% CI: [-1.33, 0]
Secondary
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 2 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Week 2 (n = 42, 40, 34) | 34.2 Unit on a scale | Standard Deviation 17.39 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Week 4 (n = 42, 37, 42) | 34.7 Unit on a scale | Standard Deviation 19.4 |
| PF-05089771 150 mg BID | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Baseline (n = 44, 45, 45） | 40.6 Unit on a scale | Standard Deviation 17.33 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Week 4 (n = 42, 37, 42) | 42.7 Unit on a scale | Standard Deviation 27.23 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Baseline (n = 44, 45, 45） | 53.4 Unit on a scale | Standard Deviation 19.35 |
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Week 2 (n = 42, 40, 34) | 44.6 Unit on a scale | Standard Deviation 24.64 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Week 2 (n = 42, 40, 34) | 44.7 Unit on a scale | Standard Deviation 18.11 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Baseline (n = 44, 45, 45） | 50.7 Unit on a scale | Standard Deviation 16.87 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) - Total Score | Week 4 (n = 42, 37, 42) | 44.5 Unit on a scale | Standard Deviation 20.18 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-5.12, 4.57]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-10.57, -0.66]
Secondary
Number of Days Participants Take Rescue Medication
Number of days participants take rescue medication per week.
Time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Number of Days Participants Take Rescue Medication | Baseline (n = 44, 46, 45) | 2.8 days | Standard Deviation 3.49 |
| PF-05089771 150 mg BID | Number of Days Participants Take Rescue Medication | Week 3 (n = 42, 42, 43) | 2.1 days | Standard Deviation 3 |
| PF-05089771 150 mg BID | Number of Days Participants Take Rescue Medication | Week 4 (n = 42, 38, 43) | 1.9 days | Standard Deviation 2.8 |
| PF-05089771 150 mg BID | Number of Days Participants Take Rescue Medication | Week 1 (n = 44, 46, 45) | 2.3 days | Standard Deviation 3.16 |
| PF-05089771 150 mg BID | Number of Days Participants Take Rescue Medication | Week 2 (n = 44, 45, 44) | 2.0 days | Standard Deviation 3.08 |
| Pregabalin | Number of Days Participants Take Rescue Medication | Week 2 (n = 44, 45, 44) | 1.7 days | Standard Deviation 2.63 |
| Pregabalin | Number of Days Participants Take Rescue Medication | Week 1 (n = 44, 46, 45) | 1.8 days | Standard Deviation 2.74 |
| Pregabalin | Number of Days Participants Take Rescue Medication | Baseline (n = 44, 46, 45) | 2.1 days | Standard Deviation 3.02 |
| Pregabalin | Number of Days Participants Take Rescue Medication | Week 4 (n = 42, 38, 43) | 1.6 days | Standard Deviation 2.55 |
| Pregabalin | Number of Days Participants Take Rescue Medication | Week 3 (n = 42, 42, 43) | 1.2 days | Standard Deviation 2.35 |
| Placebo | Number of Days Participants Take Rescue Medication | Week 4 (n = 42, 38, 43) | 1.1 days | Standard Deviation 2.28 |
| Placebo | Number of Days Participants Take Rescue Medication | Week 3 (n = 42, 42, 43) | 1.0 days | Standard Deviation 2.1 |
| Placebo | Number of Days Participants Take Rescue Medication | Baseline (n = 44, 46, 45) | 1.6 days | Standard Deviation 2.6 |
| Placebo | Number of Days Participants Take Rescue Medication | Week 1 (n = 44, 46, 45) | 1.5 days | Standard Deviation 2.5 |
| Placebo | Number of Days Participants Take Rescue Medication | Week 2 (n = 44, 45, 44) | 1.2 days | Standard Deviation 2.25 |
Secondary
Number of Participants With Laboratory Test Values of Potential Clinical Importance
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
Time frame: Screening, Day 1, Day 15 and Day 29
Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-05089771 150 mg BID | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 38 Participants |
| Pregabalin | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 35 Participants |
| Placebo | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 37 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Time frame: Screening to Day 36, and Day 64
Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05089771 150 mg BID | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Participants with TEAEs | 16 Participants |
| PF-05089771 150 mg BID | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Participants with SAE | 1 Participants |
| PF-05089771 150 mg BID | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Withdrawals due to AEs | 1 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Participants with TEAEs | 24 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Participants with SAE | 1 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Withdrawals due to AEs | 5 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Withdrawals due to AEs | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Participants with SAE | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) | Participants with TEAEs | 17 Participants |
Secondary
Patient's Global Impression of Change Score (PGIC).
Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, Improved, No Change and Worse.
Time frame: Baseline, Week 2, and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | Improved (Baseline, n = 43, 46, 45) | 20 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | Improved (Week 4, n = 42, 38, 42) | 28 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | No change (Week 4, n = 42, 38, 42) | 12 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | Worse (Week 2, n = 42, 41, 43) | 5 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | Worse (Week 4, n = 42, 38, 42) | 2 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | Improved (Week 2, n = 42, 41, 43) | 27 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | No change (Baseline, n = 43, 46, 45) | 19 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | No change (Week 2, n = 42, 41, 43) | 10 Number of participants |
| PF-05089771 150 mg BID | Patient's Global Impression of Change Score (PGIC). | Worse (Baseline, n = 43, 46, 35) | 4 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | Worse (Week 4, n = 42, 38, 42) | 2 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | Improved (Baseline, n = 43, 46, 45) | 11 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | Improved (Week 2, n = 42, 41, 43) | 30 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | Improved (Week 4, n = 42, 38, 42) | 27 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | No change (Baseline, n = 43, 46, 45) | 30 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | No change (Week 4, n = 42, 38, 42) | 9 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | Worse (Baseline, n = 43, 46, 35) | 5 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | Worse (Week 2, n = 42, 41, 43) | 4 Number of participants |
| Pregabalin | Patient's Global Impression of Change Score (PGIC). | No change (Week 2, n = 42, 41, 43) | 7 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | Worse (Baseline, n = 43, 46, 35) | 4 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | Worse (Week 4, n = 42, 38, 42) | 4 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | No change (Week 4, n = 42, 38, 42) | 14 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | Improved (Baseline, n = 43, 46, 45) | 16 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | No change (Week 2, n = 42, 41, 43) | 13 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | No change (Baseline, n = 43, 46, 45) | 25 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | Improved (Week 2, n = 42, 41, 43) | 26 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | Worse (Week 2, n = 42, 41, 43) | 4 Number of participants |
| Placebo | Patient's Global Impression of Change Score (PGIC). | Improved (Week 4, n = 42, 38, 42) | 24 Number of participants |
Comparison: Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.90% CI: [0.34, 1.45]
Comparison: Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.90% CI: [0.24, 1.07]
Secondary
Plasma Concentration of PF-05089771
All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
Time frame: Baseline, Week 2 and Week 4
Population: The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Plasma Concentration of PF-05089771 | Baseline (n = 43) | NA ng/ml | — |
| PF-05089771 150 mg BID | Plasma Concentration of PF-05089771 | Week 2 (n = 41) | 7673 ng/ml | Standard Deviation 4861 |
| PF-05089771 150 mg BID | Plasma Concentration of PF-05089771 | Week 4 (n = 41) | 8784 ng/ml | Standard Deviation 5749 |
Secondary
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
Time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05089771 150 mg BID | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 1 (n = 44, 46, 45) | 9.09 Percentage of participants |
| PF-05089771 150 mg BID | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 4 (n = 42, 38, 43) | 28.57 Percentage of participants |
| PF-05089771 150 mg BID | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 2 (n = 44, 45, 44) | 22.73 Percentage of participants |
| PF-05089771 150 mg BID | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 3 (n = 42, 42, 43) | 23.81 Percentage of participants |
| Pregabalin | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 4 (n = 42, 38, 43) | 31.58 Percentage of participants |
| Pregabalin | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 3 (n = 42, 42, 43) | 26.19 Percentage of participants |
| Pregabalin | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 2 (n = 44, 45, 44) | 31.11 Percentage of participants |
| Pregabalin | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 1 (n = 44, 46, 45) | 15.22 Percentage of participants |
| Placebo | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 4 (n = 42, 38, 43) | 16.28 Percentage of participants |
| Placebo | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 1 (n = 44, 46, 45) | 4.44 Percentage of participants |
| Placebo | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 2 (n = 44, 45, 44) | 9.09 Percentage of participants |
| Placebo | Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 3 (n = 42, 42, 43) | 11.63 Percentage of participants |
Comparison: Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.90% CI: [0.78, 4.69]
Comparison: Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.90% CI: [1.06, 6.56]
Secondary
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05089771 150 mg BID | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 3 (n = 42, 42, 43) | 7.14 Percentage of participants |
| PF-05089771 150 mg BID | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 2 (n = 44, 45, 44) | 11.36 Percentage of participants |
| PF-05089771 150 mg BID | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 1 (n = 44, 46, 45) | 0 Percentage of participants |
| PF-05089771 150 mg BID | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 4 (n = 42, 38, 43) | 9.52 Percentage of participants |
| Pregabalin | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 2 (n = 44, 45, 44) | 15.56 Percentage of participants |
| Pregabalin | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 1 (n = 44, 46, 45) | 4.35 Percentage of participants |
| Pregabalin | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 4 (n = 42, 38, 43) | 23.68 Percentage of participants |
| Pregabalin | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 3 (n = 42, 42, 43) | 19.05 Percentage of participants |
| Placebo | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 1 (n = 44, 46, 45) | 4.44 Percentage of participants |
| Placebo | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 4 (n = 42, 38, 43) | 6.98 Percentage of participants |
| Placebo | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 3 (n = 42, 42, 43) | 2.33 Percentage of participants |
| Placebo | Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score | Week 2 (n = 44, 45, 44) | 2.27 Percentage of participants |
Comparison: Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.90% CI: [0.33, 4.74]
Comparison: Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.90% CI: [1.43, 15.81]
Secondary
Total Amount of Rescue Medication Per Week
Total amount of rescue medication participants take per week
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The full analysis set included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05089771 150 mg BID | Total Amount of Rescue Medication Per Week | Week 3 (n = 42, 42, 43) | 1851 mg | Standard Deviation 3228 |
| PF-05089771 150 mg BID | Total Amount of Rescue Medication Per Week | Week 2 (n = 44, 45, 44) | 1669 mg | Standard Deviation 3248 |
| PF-05089771 150 mg BID | Total Amount of Rescue Medication Per Week | Baseline (n = 44, 46, 45) | 2726 mg | Standard Deviation 4310 |
| PF-05089771 150 mg BID | Total Amount of Rescue Medication Per Week | Week 1 (n = 44, 46, 45) | 2272 mg | Standard Deviation 4043 |
| PF-05089771 150 mg BID | Total Amount of Rescue Medication Per Week | Week 4 (n = 42, 38, 43) | 1617 mg | Standard Deviation 2945 |
| Pregabalin | Total Amount of Rescue Medication Per Week | Week 2 (n = 44, 45, 44) | 2952 mg | Standard Deviation 5488 |
| Pregabalin | Total Amount of Rescue Medication Per Week | Baseline (n = 44, 46, 45) | 3398 mg | Standard Deviation 5723 |
| Pregabalin | Total Amount of Rescue Medication Per Week | Week 1 (n = 44, 46, 45) | 2897 mg | Standard Deviation 5605 |
| Pregabalin | Total Amount of Rescue Medication Per Week | Week 3 (n = 42, 42, 43) | 1885 mg | Standard Deviation 4918 |
| Pregabalin | Total Amount of Rescue Medication Per Week | Week 4 (n = 42, 38, 43) | 2328 mg | Standard Deviation 5256 |
| Placebo | Total Amount of Rescue Medication Per Week | Week 4 (n = 42, 38, 43) | 1372 mg | Standard Deviation 3307 |
| Placebo | Total Amount of Rescue Medication Per Week | Week 3 (n = 42, 42, 43) | 1306 mg | Standard Deviation 3308 |
| Placebo | Total Amount of Rescue Medication Per Week | Baseline (n = 44, 46, 45) | 1863 mg | Standard Deviation 3684 |
| Placebo | Total Amount of Rescue Medication Per Week | Week 2 (n = 44, 45, 44) | 1391 mg | Standard Deviation 3238 |
| Placebo | Total Amount of Rescue Medication Per Week | Week 1 (n = 44, 46, 45) | 1694 mg | Standard Deviation 3425 |
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-1161, 1544]
Comparison: Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.90% CI: [-735, 1956]