Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients 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:

• Visual Analogue Scale (VAS) of pain is higher than 40 mm.

• Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

• Malignancy within the past 2 years.

• Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain