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NCT00981617 · ClinicalTrials.gov registry record · Phase 2
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
A Phase 2 study of Alcohol Dependence, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 406
- Enrollment target
- 20
- Study locations
NCT00981617: Completed Phase 2 study of Alcohol Dependence, sponsored by Alkermes.
NCT00981617 is a Phase 2 study of Alcohol Dependence that has completed, run by Alkermes. The registered enrollment target is 406 participants, above the 304-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00981617, a Phase 2 study of Alcohol Dependence, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 406 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALKS33 (RDC-0313) (1 mg)
- DRUG ALKS33 (RDC-0313) (2.5 mg)
- DRUG ALKS33 (RDC-0313) (10 mg)
Study Locations (20)
Florida
- Alkermes Investigational Site - Jacksonville
- Alkermes Investigational Site - Maitland
- Alkermes Investigational Site - Orlando
- Alkermes Investigational Site - South Miami
- Alkermes Investigational Site - West Palm Beach
California
- Alkermes Investigational Site - Cerritos
- Alkermes Investigational Site - Oceanside
- Alkermes Investigational Site - Pico Rivera
- Alkermes Investigational Site - San Diego
Georgia
- Alkermes Investigational Site - Atlanta
- Alkermes Investigational Site - Atlanta
- Alkermes Investigational Site - Roswell
New York
- Alkermes Investigational Site - Brooklyn
- Alkermes Investigational Site - New York
Arizona
- Alkermes Investigational Site - Tucson
Indiana
- Alkermes Investigational Site - Lafayette
Massachusetts
- Alkermes Investigational Site - Fall River
Nevada
- Alkermes Investigational Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00981617 record still lists
NCT00981617 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, above the 304-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00981617 names 20 study sites across 10 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00981617 about?
NCT00981617 is a clinical study titled "ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence". This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.
What is the current status of trial NCT00981617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 406 participants. The study started on 2009-10. Estimated completion is 2010-08.
What conditions does trial NCT00981617 study?
This clinical trial studies the following conditions: Alcohol Dependence.
What interventions are being tested in trial NCT00981617?
The interventions under investigation include: Placebo (DRUG), ALKS33 (RDC-0313) (1 mg) (DRUG), ALKS33 (RDC-0313) (2.5 mg) (DRUG), ALKS33 (RDC-0313) (10 mg) (DRUG).
Who is sponsoring clinical trial NCT00981617?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00981617 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00981617's enrollment target sits among peer trials
406 4th of 43 higher than 40 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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