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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 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.

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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

Alcohol Dependence

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

FieldValue
Enrollment Target 406 participants
Start Date 2009-10
Est. Completion 2010-08
Phase Phase 2

Sponsor

Alkermes

66 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00981617

The ClinicalTrials.gov registry entry for NCT00981617 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 304-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (34% higher). The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.