Status:
COMPLETED
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipatio...
Eligibility Criteria
Inclusion
- Men and women 18 years or older.
- A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
- A history of constipation due to opioid use during 1 month before the screening visit.
Exclusion
- A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
- A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
- A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
- A history of chronic constipation before initiation of opioid therapy.
Key Trial Info
Start Date :
December 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2010
Estimated Enrollment :
1040 Patients enrolled
Trial Details
Trial ID
NCT00804141
Start Date
December 3 2008
End Date
September 20 2010
Last Update
October 18 2019
Active Locations (120)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35242
2
Pfizer Investigational Site
Chandler, Arizona, United States, 85224
3
Pfizer Investigational Site
Mesa, Arizona, United States, 85206
4
Pfizer Investigational Site
Mesa, Arizona, United States, 85213