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Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00402038
Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
134
Enrollment
1
Location
2
Arms
20
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Condition or Disease Intervention/Treatment Phase
  • Drug: SC Methylnaltrexone
  • Drug: SC Placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
134 participants
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.
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Oct 1, 2005
Actual Study Completion Date :
Oct 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: SC Methylnaltrexone
Dose 1
Placebo Comparator: Arm 2

Drug: SC Placebo

Outcome Measures

Primary Outcome Measures

  1. Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Progenics Pharmaceuticals, Inc. Tarrytown New York United States 10591

Sponsors and Collaborators

  • Bausch Health Americas, Inc.
  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00402038
Other Study ID Numbers:
  • MNTX 302
First Posted:
Nov 22, 2006
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Constipation
Methylnaltrexone

Study Results

No Results Posted as of Nov 25, 2019