NCT00835718

A Study of MK0594 in Patients With Alcohol Dependence (0594-020)

A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Comparator: MK0594 5 mg/day	MK0594 5 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 15 mg MK0594 will be administered.
DRUG	Comparator: MK0594 1 mg/day	MK0594 1 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.
DRUG	Comparator: MK0594 1 mg/week	MK0594 1 mg tablets taken orally once every 7 days for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.
DRUG	Comparator: Placebo to MK0594	Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

Timeline

• Start date: 2009-02-27
• Primary completion: 2010-03-11
• Completion: 2010-03-11
• First posted: 2009-02-04
• Last updated: 2021-05-20

Regulatory

• FDA-regulated drug study