A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
- Registration Number
- NCT00394901
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
- Visual Analogue Scale (VAS) of pain is higher than 40 mm.
- Pain is sustained for more than 3 months after healing of herpes zoster skin rash.
- Malignancy within the past 2 years.
- Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
- Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
- Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
- Skin conditions in the affected dermatome that could alter sensation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Pregabalin 150mg/day Pregabalin - Pregabalin 300mg/day Pregabalin - Pregabalin 600mg/day Pregabalin -
- Primary Outcome Measures
Name Time Method Mean Pain Scores at Endpoint Week13/discontinuation Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations Week13/discontinuation Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Number of Responders Week13/discontinuation A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Mean Pain Scores at Week 1 Week 1 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 2 Week 2 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 3 Week 3 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 4 Week4 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 5 Week 5 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 6 Week 6 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 7 Week 7 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 8 Week 8 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 9 Week 9 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 10 Week 10 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 11 Week 11 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 12 Week 12 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 13 Week 13 Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
- Secondary Outcome Measures
Name Time Method Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire Week13/discontinuation Sensory score range from 0-33. Higher scores indicate more severe pain.
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire Week13/discontinuation Affective score range from 0-12. Higher scores indicate more severe pain.
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire Week13/discontinuation Total score range from 0-45. Higher scores indicate more severe pain.
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire Week13/discontinuation Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire Week13/discontinuation Present pain intensity score range from 0-5. Higher scores indicate more severe pain.
Mean Sleep Interference Scores at Endpoint Week13/discontinuation Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance Week13/discontinuation Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring Week13/discontinuation Score range for snoring is 0-100.Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache Week13/discontinuation Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep Week13/discontinuation Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy Week13/discontinuation Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence Week13/discontinuation Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index Week13/discontinuation Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep Week13/discontinuation Number of participants who reported Optimal Sleep
Endpoint Patient Global Impression Change Week13/discontinuation Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Endpoint Clinical Global Impression Change Week13/discontinuation Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: Vitality Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health Week13/discontinuation Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Number of Patients Not Reporting Allodynia Week13/discontinuation Participants not reporting allodynia.
Number of Patients Not Reporting Hyperalgesia Week13/discontinuation Participants not reporting hyperalgesia.
Mean Sleep Interference Scores at Week 1 week 1 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 2 week 2 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 3 week 3 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 4 week 4 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 5 week 5 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 6 week 6 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 7 week 7 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 9 week 9 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 8 week 8 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 10 week 10 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 11 week 11 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 12 week 12 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Mean Sleep Interference Scores at Week 13 week 13 Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Saitama, Japan