A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain
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MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in order to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in subjects with chronic, non-malignant pain.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone (OM) for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic, Non-Malignant Pain
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
History of chronic non-malignant pain (originating from a non-malignant source).
Taking oral, transdermal, intravenous, or subcutaneous opioids for chronic non-malignant pain.
No known history of chronic constipation prior to the initiation of opioid therapy.
Currently taking laxative therapy and willing to discontinue all laxative therapy pre-study and use only study-permitted rescue laxatives.
Key Exclusion Criteria:
Prior treatment with oral methylnaltrexone.
Prior treatment with SC methylnaltrexone within 30 days pre-study.
Women who are pregnant, breastfeeding, or plan to become pregnant.
Gastrointestinal disorders known to affect bowel transit.
Current treatment with partial opioid agonists (e.g., buprenorphine) or combination agonists/antagonists.