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OpenTrials
Completed

NCT Number: NCT00401362

A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

To test the effectiveness of MNTX in advanced illness subjects.

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Key information

Conditions

Advanced Illness Patients With Opioid Induced Constipation

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

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Advanced medical illness with a life expectancy of 1 to 6 months
  • No clinically significant laxation within 48 hours prior to the first dose of study drug
  • On stable opioid and laxative regimen for a least 3 days prior to treatment
  • Age greater than 18years
  • Females of child-bearing age must have a negative pregnancy test.

Exclusion criteria

  • Females who are pregnant or nursing.
  • Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
  • Any disease process suggestive of gastrointestinal obstruction
  • Fecal ostomy.

Treatment and study plan

SC Methylnaltrexone

Drug

Dose 1

SC Placebo

Drug

Primary outcomes

  1. Efficacy of SC MNTX compared with placebo in inducing laxation

    Time frame: 29 days

    The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Nov 20, 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.