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Completed

NCT Number: NCT00672477

Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Salix Investigational Site, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is an adult 18 years of age or older
  • Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
  • Has a life expectancy of at least 1 month.
  • Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
  • Has constipation that is caused by opioid medications.

Exclusion criteria

  • Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
  • Has a known or suspected mechanical gastrointestinal obstruction.
  • Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
  • Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
  • Receiving opioid antagonist or partial antagonist products.

Treatment and study plan

methylnaltrexone

Drug

Other names: MOA-728, Relistor

Placebo

Drug

Other names: Control

Primary outcomes

  1. The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses

    Time frame: 7 days

    This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.

Secondary outcomes

  1. Time to First Rescue-free Laxation (Following the First Dose of Study Drug).

    Time frame: 14 days

    This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 6, 2008
Registry last updated
Mar 8, 2018

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.

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