Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.

Phase 3

Completed

• Conditions: Diabetic Neuropathy, Painful

• Registration Number: NCT00141401
• Lead Sponsor: Pfizer

Brief Summary

To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Study Completion: 2005-07
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-15
• Last Update Posted: 2007-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Must have met the inclusion criteria for preceding double-blind study
• Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study.

Exclusion Criteria

• Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety Efficacy