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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00835718
• Other study ID #: 0594-020
• Secondary ID: MK0594-0202009_5
• Status: Terminated
• Phase: Phase 2
• Start date: February 27, 2009
• Est. completion date: March 11, 2010

Study information

• Verified date: May 2021
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 162
• Est. completion date: March 11, 2010
• Est. primary completion date: March 11, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction

• Patient has two heavy drinking days in the last 30 days

• Patient has 3 days of abstinence from alcohol right before taking study medication

• Patient has lived in the same residence for the last 2 months

Exclusion Criteria:

• If female, patient is pregnant or breastfeeding

• Patient anticipated inpatient alcohol treatment

• Patient has a history of suicide attempt in the last year

• Patient has schizophrenia or bipolar disorder

• Patient has a history of multiple or serious allergies

• Patient has participated in a clinical trial in the last 30 days

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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.
• 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.
• 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.
• Comparator: Placebo to MK0594
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination	no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination	week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety
Secondary	no alcohol drinking	no alcohol drinking	week 3 to 12 after starting study medication and over 52 weeks