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

Completed · Phase 4 · Has a placebo group

Conditions studied: Opioid-Induced Constipation

In brief

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.

Key facts

Study ID

NCT00672477

Run by

Bausch Health Americas, Inc.

People needed

237

Starts

2008-06-01

Expected to finish

2013-02-01

Last updated by the study team

2018-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Salix Investigational Site — Laguna Hills, California, United States
• Salix Investigational Site — Lancaster, California, United States
• Salix Investigational Site — Aurora, Colorado, United States
• Salix Investigational Site — Auburndale, Florida, United States
• Salix Investigational Site — Hudson, Florida, United States
• Salix Investigational Site — Lakeland, Florida, United States
• Salix Investigational Site — Lakeland, Florida, United States
• Salix Investigational Site — Miami Springs, Florida, United States
• Salix Investigational Site — Ruskin, Florida, United States
• Salix Investigational Site — Sebring, Florida, United States
• Salix Investigational Site — Tampa, Florida, United States
• Salix Investigational Site — Tampa, Florida, United States
• Salix Investigational Site — Tampa, Florida, United States
• Salix Investigational Site — Temple Terrace, Florida, United States
• Salix Investigational Site — West Palm Beach, Florida, United States
• Salix Investigational Site — Orange, New Jersey, United States
• Salix Investigational Site — Albuquerque, New Mexico, United States
• Salix Investigational Site — Flat Rock, North Carolina, United States
• Salix Investigational Site — Winston-Salem, North Carolina, United States
• Salix Investigational Site — Cleveland, Ohio, United States
• Salix Investigational Site — Philadelphia, Pennsylvania, United States
• Salix Investigational Site — Austin, Texas, United States
• Salix Investigational Site — Houston, Texas, United States
• Salix Investigational Site — American Fork, Utah, United States
• Salix Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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