Alcohol DependencePhase 2NCT00835718
A Study of MK0594 in Patients With Alcohol Dependence (0594-020)
A Phase 2 study testing Comparator: MK0594 5 mg/day, Comparator: MK0594 1 mg/day and Comparator: MK0594 1 mg/week in people with Alcohol Dependence, run by Vyne Therapeutics Inc..
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Comparator: MK0594 5 mg/day, Comparator: MK0594 1 mg/day and Comparator: MK0594 1 mg/week
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2009to 11 Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- Comparator: MK0594 5 mg/day, Comparator: MK0594 1 mg/day, Comparator: MK0594 1 mg/week, Comparator: Placebo to MK0594
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: MK0594 5 mg/dayDrug
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/dayDrug
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/weekDrug
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 MK0594Drug
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Stage I, Arm 1 | Experimental | MK0594 5 mg/day Receives: Drug: Comparator: MK0594 5 mg/day |
| Stage I, Arm 2 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo to MK0594 |
| Stage II, Arm 2 | Experimental | MK0594 1 mg/day Receives: Drug: Comparator: MK0594 1 mg/day |
| Stage II, Arm 3 | Experimental | MK0594 1 mg/week Receives: Drug: Comparator: MK0594 1 mg/week |
| Stage II, Arm 4 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo to MK0594 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety
Secondary outcomes (1)
no alcohol drinking
no alcohol drinking
Measured: week 3 to 12 after starting study medication and over 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study start27 Feb 2009
- Primary completion11 Mar 2010
- Study completion11 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Menlo Therapeutics Inc., Study director, Vyne Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835718
- Sponsor's protocol ID
- 0594-020
- Other IDs
- MK0594-020, 2009_533
- Status last verified
- May 2021
- First submitted
- 3 Feb 2009
- Last updated
- 20 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00835718
- Acronym / sponsor ID
- 0594-020
- Conditions
- Alcohol Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2009 (actual)
- Primary completion
- 11 Mar 2010 (actual)
- Study completion
- 11 Mar 2010 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage I, Arm 1 | Experimental | Drug: Comparator: MK0594 5 mg/dayMK0594 5 mg/day |
| Stage I, Arm 2 | Placebo comparator | Drug: Comparator: Placebo to MK0594Placebo |
| Stage II, Arm 2 | Experimental | Drug: Comparator: MK0594 1 mg/dayMK0594 1 mg/day |
| Stage II, Arm 3 | Experimental | Drug: Comparator: MK0594 1 mg/weekMK0594 1 mg/week |
| Stage II, Arm 4 | Placebo comparator | Drug: Comparator: Placebo to MK0594Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: MK0594 5 mg/dayMK0594 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 | Stage I, Arm 1 |
| Comparator: MK0594 1 mg/dayMK0594 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 | Stage II, Arm 2 |
| Comparator: MK0594 1 mg/weekMK0594 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 | Stage II, Arm 3 |
| Comparator: Placebo to MK0594Matching placebo to MK0594 tablets taken orally once daily for 12 weeks. | Drug | Stage I, Arm 2, Stage II, Arm 4 |
Primary outcome
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
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
1 secondary outcome
no alcohol drinking
Time frame: week 3 to 12 after starting study medication and over 52 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menlo Therapeutics Inc. study director
Vyne Therapeutics Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comparator: MK0594 5 mg/day, Comparator: MK0594 1 mg/day and Comparator: MK0594 1 mg/week in people with Alcohol Dependence, run by Vyne Therapeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.