Status:
COMPLETED
A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Advanced Illness Patients With Opioid Induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To test the effectiveness of MNTX in advanced illness subjects.
Detailed Description
To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00401362
Start Date
February 1 2003
End Date
February 1 2005
Last Update
November 25 2019
Active Locations (1)
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1
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591