E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001590 |
E.1.2 | Term | Alcohol addiction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the clinical efficacy of 12 weeks of treatment with Vivitrol (naltrexone for extended-release injectable suspension, 380 mg) vs placebo administered to adults every 4 weeks upon discharge from inpatient treatment for alcohol dependence. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the clinical safety and efficacy of Vivitrol administered every 4 weeks in the treatment of alcohol dependent adults as assessed by secondary and exploratory endpoints.
To assess longer-term safety, durability of effect, and health economic measures. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Capable of understanding and complying with the protocol, and has signed the informed consent document • Current diagnosis of alcohol dependence, meeting at least 5 of the DSM-IV criteria • 18 years of age or older • Must be expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization • Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose • Must be free of symptoms and/or signs of acute alcohol withdrawal on the day of randomization • Must have a non-custodial stable residence and a telephone, plus one contact with verifiable address and telephone number • Must have a negative urine toxicological screen for opioids and benzodiazepines on the day of randomization • If subject is female and of child-bearing potential, she must agree to use an acceptable method of contraception for the duration of the study. |
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E.4 | Principal exclusion criteria |
• Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding • Clinically significant medical condition or observed abnormalities (including: physical examination, ECG, laboratory evaluation, and/or urinalysis findings) • Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease • Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal • History of pancreatitis • Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the subject’s ability to complete the study. • Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM IV criteria • Current seizure disorder • Current eating disorder • Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period • Use of oral naltrexone, acamprosate, or disulfiram within 30 days prior to screening • Use of any excluded medication at screening or anticipated/required use during the study period • Receipt of any approved or investigational depot product administered into the gluteal muscle within 6 months of screening • Participation in a clinical trial of a pharmacological agent within 30 days prior to screening • Previous enrollment in a Vivitrol (or Medisorb® Naltrexone) clinical trial • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG • Any finding that in the view of the Principal Investigator would compromise the subject’s ability to fulfill the protocol visit schedule or visit requirements. • Subjects on parole or probation, or those with pending legal proceedings that have the potential for incarceration during the study period
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the percent of days abstinent from any alcohol. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |