Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Painful Diabetic Peripheral Neuropathy

In brief

This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.

Key facts

Study ID

NCT01455415

Run by

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

People needed

306

Starts

2011-12-01

Expected to finish

2013-12-01

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…

• Type 1 or 2 diabetes with painful neuropathy
• Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
• Meet pre-defined level of pain severity at entrance

You may not qualify if…

• History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
• Participated in a previous or ongoing pregabalin clinical trial
• Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain

Where it is running

• Clinical Research Consortium — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Advanced Podiatry — Phoenix, Arizona, United States
• Precision Trials — Phoenix, Arizona, United States
• The Office of Joshua D. Holland, M.D. — Phoenix, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Center for United Research, Inc. — Lakewood, California, United States
• HealthCare Partners Medical Group — Los Angeles, California, United States
• IDS Pharmacy — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• Neurological Group, PC — New London, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Meridien Research — Bradenton, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• AGA Clinical Trials — Hialeah, Florida, United States
• Palm Beach Neurological Center, — Palm Beach Gardens, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Dedicated Clinical Research — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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