Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Advance Illness Patients With OIC Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402038
• Other study ID #: MNTX 302
• Status: Completed
• Phase: Phase 3
• Start date: February 2004
• Est. completion date: October 2005

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Illness Patients With OIC
• Constipation

Intervention

Drug:
• SC Methylnaltrexone
Dose 1
• SC Placebo

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.	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.	2 weeks

External Links

•   Link