Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00838799|
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : July 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Peripheral Neuropathic Pain||Drug: RGH-896 Drug: pregabalin Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||458 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain|
|Study Start Date :||February 2009|
|Primary Completion Date :||April 2010|
45 mg TID, capsules, 14 weeks.
30 mg TID, capsules, 14 weeks.
15 mg TID, capsules, 14 weeks.
|Active Comparator: 4||
100 mg, TID, capsules, 14 weeks.
Other Name: Lyrica
|Placebo Comparator: 5||
TID, capsules, 14 weeks.
- Change in mean daily pain rating [ Time Frame: Baseline to Week 14 ]
- 50% reduction in pain [ Time Frame: Baseline to Week 14 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838799
Show 54 Study Locations
|Study Director:||Allyson Gage, PhD||Forest Research Institute, a subsidiary of Forest Laboratories Inc.|