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Study of Methylnaltrexone (MNTX) for the Relief of Constipation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00402038
First Posted: November 22, 2006
Last Update Posted: July 19, 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.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Condition Intervention Phase
Advance Illness Patients With OIC Drug: SC Methylnaltrexone Drug: SC Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. [ Time Frame: 2 weeks ]

    To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours.

    To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.



Enrollment: 134
Study Start Date: February 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SC Methylnaltrexone
Dose 1
Placebo Comparator: Arm 2 Drug: SC Placebo

Detailed Description:
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
  • Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
  • patient must sign ICF

Exclusion Criteria:

  • Women who are pregnant and/or nursing
  • Previous treatment with MNTX
  • Participation in any other studies involving investigational products within 30 days prior to screening
  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): NCT00402038


Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00402038     History of Changes
Other Study ID Numbers: MNTX 302
First Submitted: November 17, 2006
First Posted: November 22, 2006
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents