Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
NCT00804141
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation | |||
Official Title ICMJE | An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain | |||
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 constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Constipation | |||
Intervention ICMJE | Drug: N-methylnaltrexone bromide (MOA-728)
MOA-728 will be administered as per the dose and schedule specified in the arm. Other Name: Relistor | |||
Study Arms ICMJE | Experimental: MOA-728 12 mg QD
Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day. Intervention: Drug: N-methylnaltrexone bromide (MOA-728) | |||
Publications * | Webster R, Michna E, Khan A, et al., The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain. J. Pain, 12(4), Supplement , Page P70, April 2011 | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1040 | |||
Original Estimated Enrollment ICMJE | 800 | |||
Actual Study Completion Date ICMJE | September 20, 2010 | |||
Actual Primary Completion Date | September 20, 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Canada, Colombia, Korea, Republic of, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00804141 | |||
Other Study ID Numbers ICMJE | 3200K1-3358 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Bausch Health Americas, Inc. | |||
Study Sponsor ICMJE | Bausch Health Americas, Inc. | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Bausch Health Americas, Inc. | |||
Verification Date | September 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |