Health Condition 1: null- Post Herpetic Neuralgia
Conditions
Interventions
Intervention1: Pregablain CR tablet 82.5 to 660mg: Drug: Pregabalin
Tablets, 82.5 to 660mg, once per day.
Duration: 19 weeks
Control Intervention1: Placebo Comparator: Drug: placebo
Placebo, 82.5
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Bulgaria, Croatia, Czech Republic, Denmark, Germany, India, Other, Poland, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, United States of America
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed