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

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced Illness Patients With Opioid Induced Constipation

In brief

To test the effectiveness of MNTX in advanced illness subjects.

Key facts

Study ID

NCT00401362

Run by

Bausch Health Americas, Inc.

People needed

154

Starts

2003-02-01

Expected to finish

2005-02-01

Last updated by the study team

2019-11-25

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Progenics Pharmaceuticals, Inc. — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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