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Completed

NCT Number: NCT01367574

Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

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Key information

Conditions

Bowel Dysfunction Chemically-Induced Disorders Constipation Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation 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 2

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
  • Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
  • Must have constipation
  • Must be 18 yrs or older

Exclusion criteria

  • Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
  • Patients who received any experimental drug in the last 30 days
  • Patients with active peritoneal cancer (ovarian, etc.)
  • Patients with active diverticulitis or diverticulosis

Treatment and study plan

SC MNTX

Drug

Dose 1

Primary outcomes

  1. Number of subjects who have a bowel movement within four hours of dosing

    Time frame: Up to 4 weeks

    To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Secondary outcomes

  1. Number of subject with Adverse Events

    Time frame: Up to 4 weeks

    To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jun 7, 2011
Registry last updated
Nov 27, 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.

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