Trials / Completed
CompletedNCT01345045
A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-639 | ABT-639 Twice Daily for six weeks. |
| DRUG | pregabalin | pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study. |
| DRUG | Placebo | Placebo twice daily for 6 weeks. |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2011-04-29
- Last updated
- 2013-01-08
Locations
35 sites across 5 countries: United States, Czechia, France, Germany, Mexico
Source: ClinicalTrials.gov record NCT01345045. Inclusion in this directory is not an endorsement.