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

Phase 3

Completed

• Conditions: Diabetic Neuropathies

• Registration Number: NCT00143156
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Study Completion: 2007-05
• Status Verified: 2008-04
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 Ponce, Puerto Rico