Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Completed · Phase 3

Conditions studied: Diabetic Neuropathies

In brief

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Key facts

Study ID

NCT00143156

Run by

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

People needed

450

Starts

2005-03-01

Expected to finish

2007-05-01

Last updated by the study team

2021-01-22

Who can join

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

You may qualify if…

• Males or females at least 18 years of age, of any ethnic origin
• Type 1 or 2 diabetes mellitus
• Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

You may not qualify if…

• Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
• Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — La Mesa, California, United States
• Pfizer Investigational Site — Los Gatos, California, United States
• Pfizer Investigational Site — Northridge, California, United States
• Pfizer Investigational Site — Tustin, California, United States
• Pfizer Investigational Site — Walnut Creek, California, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Wheat Ridge, Colorado, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Peoria, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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