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

NCT00835718 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2021-05-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vyne Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Menlo Therapeutics Inc. · Vyne Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-27
Primary Completion
2010-03-11
Completion
2010-03-11
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835718 on ClinicalTrials.gov