Back to resultsA Study of MK0594 in Patients With Alcohol Dependence (0594-020)
Primary Purpose
Alcohol Dependence
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: MK0594 5 mg/day
Comparator: MK0594 1 mg/day
Comparator: MK0594 1 mg/week
Comparator: Placebo to MK0594
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Stage I, Arm 1
Stage I, Arm 2
Stage II, Arm 2
Stage II, Arm 3
Stage II, Arm 4
Arm Description
MK0594 5 mg/day
Placebo
MK0594 1 mg/day
MK0594 1 mg/week
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
no alcohol drinking
no alcohol drinking
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00835718
Brief Title
A Study of MK0594 in Patients With Alcohol Dependence (0594-020)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Study Start Date
February 27, 2009 (Actual)
Primary Completion Date
March 11, 2010 (Actual)
Study Completion Date
March 11, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stage I, Arm 1
Arm Type
Experimental
Arm Description
MK0594 5 mg/day
Arm Title
Stage I, Arm 2
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Stage II, Arm 2
Arm Type
Experimental
Arm Description
MK0594 1 mg/day
Arm Title
Stage II, Arm 3
Arm Type
Experimental
Arm Description
MK0594 1 mg/week
Arm Title
Stage II, Arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0594 5 mg/day
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0594 1 mg/day
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0594 1 mg/week
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo to MK0594
Intervention Description
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
Primary Outcome Measure Information:
Title
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
Description
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
Time Frame
week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety
Secondary Outcome Measure Information:
Title
no alcohol drinking
Description
no alcohol drinking
Time Frame
week 3 to 12 after starting study medication and over 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menlo Therapeutics Inc.
Organizational Affiliation
Menlo Therapeutics
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of MK0594 in Patients With Alcohol Dependence (0594-020)
We'll reach out to this number within 24 hrs