We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00505583
First Posted: July 23, 2007
Last Update Posted: July 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Condition Intervention Phase
Methadone-maintenance Subjects Drug: MOA-728 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

Study Start Date: July 2007
Estimated Study Completion Date: December 2007
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  1. Healthy men or women, aged 18 to 65 years.
  2. History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.

Exclusion:

  1. History or active presence of clinically important medical disease.
  2. Allergy to opioids.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505583


Locations
United States, Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00505583     History of Changes
Other Study ID Numbers: 3200A3-1110
First Submitted: July 16, 2007
First Posted: July 23, 2007
Last Update Posted: July 25, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents