Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
- Conditions
- Health Condition 1: null- Post Herpetic Neuralgia
- Registration Number
- CTRI/2011/07/001905
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 800
1. Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
2.At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
3.At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
4.Male or female of any race, at least 18 years of age, and using appropriate methods of contraception
Kindly note that there is no upper limit for inclusion criteria in the trial.
1. Creatinine clearance lessthan 30 mL/min (estimated from serum creatinine).
2.Skin conditions in the affected dermatome that could alter sensation
3.Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to loss of therapeutic response (LTR), defined as lessthan 30% pain response relative to the baseline phase or patient discontinuation due to lack of efficacy or adverse events, in the double blind phase of the study.Timepoint: 13 weeks
- Secondary Outcome Measures
Name Time Method 8.Benefit, Satisfaction, Willingness to Continue Measure (BSW)Timepoint: 13 weeks;9.Adverse eventsTimepoint: 19 weeks;1.Pain numeric rating scale (NRS); 1 week recall periodTimepoint: 13 weeks;10.Suicidality assessments (STS)Timepoint: 13 weeks;2.Medical Outcomes Study (MOS) Sleep Scale total score and each sub domainTimepoint: 13 weeks;3.Patient Global Impression of Change (PGIC)Timepoint: 13 weeks;4.Short Form 36 Health Survey (SF 36)Timepoint: 13 weeks;5.Daily sleep interference diaryTimepoint: 13 weeks;6.Hospital Anxiety and Depression Scale (HADS)Timepoint: 13 weeks;7.Brief Pain Inventory (BPI sf).Timepoint: 13 weeks