CompletedPhase 3

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

United States450 participantsStarted 2005-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

What they're measuring

The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Trial details

NCT IDNCT00143156

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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