Diabetic Neuropathy, Painful Clinical Trial
Official title:
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
| Verified date | April 2009 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.
| Status | Completed |
| Enrollment | 167 |
| Est. completion date | October 2005 |
| 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. |
| 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 | 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 | Lake Worth | Florida |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Nerve conduction measurements; Pain scores from patient diaries | |||
| Secondary | Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04988321 -
Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
|
N/A | |
| Completed |
NCT00385671 -
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
|
Phase 4 | |
| Completed |
NCT00141401 -
Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.
|
Phase 3 | |
| Active, not recruiting |
NCT04469270 -
Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
|
Phase 3 | |
| Completed |
NCT00553475 -
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
|
Phase 3 | |
| Completed |
NCT00381719 -
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
|
Phase 2 | |
| Completed |
NCT00539175 -
Treatment of Painful Diabetic Neuropathy With Photon Stimulation
|
N/A | |
| Completed |
NCT00058968 -
A Study for the Treatment of Painful Diabetic Neuropathy
|
Phase 3 | |
| Completed |
NCT05029297 -
Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.
|
Phase 3 | |
| Completed |
NCT02215252 -
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
|
Phase 2 | |
| Completed |
NCT00785577 -
A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
|
Phase 2 | |
| Completed |
NCT00858351 -
Thermal Biofeedback for the Treatment of Diabetic Neuropathy
|
N/A | |
| Completed |
NCT03047278 -
Transporters for Organic Cations and Glycemic Control in Patients With Neuropathic Pain.
|
Phase 4 | |
| Completed |
NCT01628627 -
Frequency Modulated Neural Stimulation (FREMS) in Symptomatic Diabetic Neuropathy
|
Phase 4 | |
| Completed |
NCT03315598 -
Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
|
N/A | |
| Completed |
NCT01057693 -
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
|
Phase 3 | |
| Completed |
NCT01564459 -
Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)
|
Phase 2 | |
| Recruiting |
NCT01214590 -
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
|
N/A | |
| Completed |
NCT01089556 -
A Study in Painful Diabetic Neuropathy
|
Phase 3 | |
| Completed |
NCT00501202 -
Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).
|
Phase 2 |