Clinical Trials Logo
  1. Home
  2. Diabetic Peripheral Neuropathy
  3. NCT00159731
  4. Details
NCT00159731 Clinical Trial

Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:
An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159731
Other study ID # A0081036
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2005
Est. completion date May 2006

Study information
Verified date July 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults with Type 1 or 2 diabetes - Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months Exclusion Criteria: - Patients must not be in poor or unstable health.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

Locations
Country Name City State
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Duncansville Pennsylvania
United States Pfizer Investigational Site Englewood New Jersey
United States Pfizer Investigational Site Greenville North Carolina
United States Pfizer Investigational Site Hot Springs Arkansas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Palm Beach Gardens Florida
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Sunrise Florida
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site West Palm Beach Florida

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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events
See also
  Status Clinical Trial Phase
Recruiting NCT04638556 - Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
Completed NCT05580705 - Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy N/A
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT00835757 - Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy N/A
Recruiting NCT00553592 - Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes Phase 2
Recruiting NCT05863793 - Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy N/A
Withdrawn NCT05041816 - Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy N/A
Recruiting NCT06074562 - A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain Phase 2
Recruiting NCT04457531 - LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy Early Phase 1
Completed NCT02947828 - Polyneuropathy in Diabetes Mellitus Type 2
Completed NCT02056431 - Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy N/A
Completed NCT01681290 - Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes Phase 2
Completed NCT01474772 - Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) Phase 3
Completed NCT01086150 - Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy Phase 2/Phase 3
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Completed NCT04688671 - Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain Phase 2
Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
Completed NCT06130917 - Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN. N/A
Completed NCT01496365 - Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Phase 2

External Links