Status:
COMPLETED
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Opioid-Induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00672477
Start Date
June 1 2008
End Date
February 1 2013
Last Update
March 8 2018
Active Locations (60)
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1
Salix Investigational Site
Mobile, Alabama, United States, 36604
2
Salix Investigational Site
Laguna Hills, California, United States, 92637
3
Salix Investigational Site
Lancaster, California, United States, 93534
4
Salix Investigational Site
Aurora, Colorado, United States, 80045