Status:
COMPLETED
Safety of Subcutaneous Methylnaltrexone for 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 is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in l...
Eligibility Criteria
Inclusion
- Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
- Is receiving opioids on a regular schedule, not just as needed to control pain.
- Likely to continue to need treatment of OIC for the duration of participation in the study.
Exclusion
- Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
- Currently using an opioid antagonist or partial antagonist.
- Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00672139
Start Date
July 1 2008
End Date
May 1 2013
Last Update
March 7 2018
Active Locations (46)
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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