Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Painful Diabetic Peripheral Neuropathy

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 p...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

306 Patients enrolled

Trial Details

Trial ID

NCT01455415

Start Date

December 1 2011

End Date

December 1 2013

Last Update

January 28 2021

Active Locations (61)

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Page 1 of 16 (61 locations)

1

Dedicated Clinical Research

Goodyear, Arizona, United States, 85395

2

Clinical Research Consortium

Phoenix, Arizona, United States, 85004

3

Arizona Research Center

Phoenix, Arizona, United States, 85023

4

Advanced Podiatry

Phoenix, Arizona, United States, 85032