Study of Methylnaltrexone (MNTX) for the Relief of Constipation

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00402038
First received: November 17, 2006
Last updated: July 18, 2011
Last verified: July 2011
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402038

Locations
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
Investigators
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 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
Study First Received: November 17, 2006
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014