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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

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.