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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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:

• 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

Exclusion Criteria:

• 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