NCT00381043 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Paille FM, Guelfi JD, Perkins AC, Royer RJ, Steru L, Parot P
Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. Alcohol Alcohol. 1995 Mar;30(2):239-47.
Pelc I, Verbanck P, Le Bon O, Gavrilovic M, Lion K, Lehert P
Efficacy and safety of acamprosate in the treatment of detoxified alcohol-dependent patients. A 90-day placebo-controlled dose-finding study. Br J Psychiatry. 1997 Jul;171:73-7.
Sass H, Soyka M, Mann K, Zieglgänsberger W
Relapse prevention by acamprosate. Results from a placebo-controlled study on alcohol dependence. Arch Gen Psychiatry. 1996 Aug;53(8):673-80. Erratum in: Arch Gen Psychiatry 1996 Dec;53(12):1097.

Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study

Clinical trial NCT00381043 - References