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OpenTrials
Completed

NCT Number: NCT00402038

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

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

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Key information

Conditions

Advance Illness Patients With OIC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SC Methylnaltrexone

Drug

Dose 1

SC Placebo

Drug

Primary outcomes

  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.

    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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 22, 2006
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.