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

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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)


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
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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100 West Gore St # 202
Orlando, Florida 32806
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3540 Northwest 88th Avenue
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6261 N. La Cholla Blvd
Tucson, Arizona 85741
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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