Study of Methylnaltrexone (MNTX) for the Relief of Constipation

This study has been completed.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Salix Pharmaceuticals Identifier:
First received: November 17, 2006
Last updated: July 18, 2011
Last verified: July 2011

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Salix Pharmaceuticals:

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 ] [ Designated as safety issue: No ]

    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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00402038

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

Additional Information:
No publications provided by Salix Pharmaceuticals

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc. Identifier: NCT00402038     History of Changes
Other Study ID Numbers: MNTX 302
Study First Received: November 17, 2006
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 26, 2015