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NCT00143156 Clinical Trial

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

Diabetic Neuropathies Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143156
Other study ID # A0081071
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2005
Est. completion date May 2007

Study information
Verified date April 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• pregabalin

Locations
Country Name City State
Puerto Rico Pfizer Investigational Site Ponce
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boulder Colorado
United States Pfizer Investigational Site Burlington Vermont
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Englewood New Jersey
United States Pfizer Investigational Site Frisco Texas
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Jefferson City Missouri
United States Pfizer Investigational Site Kettering Ohio
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Los Gatos California
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site New Hyde Park New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Northridge California
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Shrewsbury New Jersey
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Springfield Illinois
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Tupelo Mississippi
United States Pfizer Investigational Site Tuscaloosa Alabama
United States Pfizer Investigational Site Tustin California
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Warwick Rhode Island
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Wheat Ridge Colorado

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
Secondary 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.
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Completed NCT01926522 - Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients N/A
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Completed NCT00135109 - Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Phase 3
Completed NCT06292962 - Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain N/A
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