Status:
COMPLETED
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Opioid-Induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid indu...
Eligibility Criteria
Inclusion
- Key
- History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit.
- Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month.
- No known history of chronic constipation prior to the initiation of opioid therapy.
- Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods..
- Key
Exclusion
- Prior treatment with oral MNTX.
- Prior treatment with SC MNTX within 30 days of screening.
- Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
- Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate.
- Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2011
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT01186770
Start Date
September 1 2010
End Date
September 8 2011
Last Update
September 6 2019
Active Locations (2)
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1
PRA International
Raleigh, North Carolina, United States, 27612
2
PRA, Intl.
Raleigh, North Carolina, United States, 27612