Trials / Completed
CompletedNCT01474772
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 217 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pregabalin | 150-300 mg/day given in 3 divided doses as capsules |
| OTHER | placebo | matching placebo capsules given in 3 divided doses |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2011-11-18
- Last updated
- 2021-01-28
- Results posted
- 2014-11-18
Locations
45 sites across 4 countries: United States, Czechia, South Africa, Sweden
Source: ClinicalTrials.gov record NCT01474772. Inclusion in this directory is not an endorsement.