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| ID | Type | Description | Link |
|---|---|---|---|
| MK0594-020 | |||
| 2009_533 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I, Arm 1 | Experimental | MK0594 5 mg/day |
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| Stage I, Arm 2 | Placebo Comparator | Placebo |
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| Stage II, Arm 2 | Experimental | MK0594 1 mg/day |
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| Stage II, Arm 3 | Experimental | MK0594 1 mg/week |
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| Stage II, Arm 4 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0594 5 mg/day | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| no alcohol drinking | no alcohol drinking | week 3 to 12 after starting study medication and over 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Menlo Therapeutics Inc. | Vyne Therapeutics Inc. | Study Director |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Comparator: MK0594 1 mg/day | Drug | 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. |
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| Comparator: MK0594 1 mg/week | Drug | 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. |
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| Comparator: Placebo to MK0594 | Drug | Matching placebo to MK0594 tablets taken orally once daily for 12 weeks. |
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