Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Herpetic Neuralgia

In brief

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)

Key facts

Study ID

NCT01270828

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

806

Starts

2011-03-01

Expected to finish

2014-11-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Radiant Research, Inc. — Chandler, Arizona, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Larry Watkins, M.D. (Private Practice) — Little Rock, Arkansas, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Hearne Family Practice Clinic — Little Rock, Arkansas, United States
• Center for Clinical Research, Inc — Carmichael, California, United States
• Community Medical Providers — Clovis, California, United States
• Sierra Medical Research — Clovis, California, United States
• Inland Pain Medicine — Colton, California, United States
• The Helm Center — Laguna Hills, California, United States
• University of Southern California — Los Angeles, California, United States
• USC IDS Pharmacy — Los Angeles, California, United States
• Translational Research Group, Inc — North Hollywood, California, United States
• George J. Rederich, M.D., Incorporated — Redondo Beach, California, United States
• Integrated Research Group, Inc. — Riverside, California, United States
• Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc. — San Diego, California, United States
• Integrated Research Center, Inc. — San Diego, California, United States
• Center For Clinical Research, Inc. — San Francisco, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Foothills Pain Management Clinic, PS — West Covina, California, United States
• Fundamental Research — Gulf Shores, Alabama, United States

Full record on ClinicalTrials.gov

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