An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence
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|ClinicalTrials.gov Identifier: NCT00210925|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: topiramate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Alcohol Dependence|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||August 2006|
- The change in percentage of heavy drinking days (5 or more standard drinking units per day for men and 4 or more standard drinking units per day for women) from baseline at 12 weeks or final visit.
- The change in each of the following: drinks/drinking day, drinks/day, percent days abstinent, Clinical Institute Withdrawal Assessment for Alcohol-revised, compared to baseline at 12 weeks or final visit.
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): NCT00210925
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|