Trials / Completed
CompletedNCT01057693
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 633 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pregabalin (Lyrica) | Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily. |
| DRUG | Placebo | Placebo is supplied as capsules and given 3 times daily. |
Timeline
- Start date
- 2010-03-31
- Primary completion
- 2012-01-30
- Completion
- 2012-01-30
- First posted
- 2010-01-27
- Last updated
- 2021-01-20
- Results posted
- 2013-02-22
Locations
172 sites across 4 countries: United States, Canada, Puerto Rico, South Africa
Source: ClinicalTrials.gov record NCT01057693. Inclusion in this directory is not an endorsement.