Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
Status: | Completed |
---|---|
Conditions: | Postherpatic Neuralgia |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2011 |
End Date: | November 2014 |
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224)
The purpose of the study is to explore the safety and efficacy of a new once a day
pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)
pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)
Inclusion Criteria:
- Patients must have pain present for more than 3 months after the healing of the
herpes zoster skin rash.
- 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).
- 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.
- Male or female of any race, at least 18 years of age, and using appropriate methods
of contraception
Exclusion Criteria:
- Creatinine clearance <30 mL/min (estimated from serum creatinine).
- Skin conditions in the affected dermatome that could alter sensation
- 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
We found this trial at
83
sites
University of Southern California The University of Southern California is one of the world’s leading...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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San Diego, California 92117
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