Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Constipation

Treatments: Drug: N-methylnaltrexone bromide (MOA-728)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804141

3200K1-3358

Details and patient eligibility

About

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.

Enrollment: 1,040 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,040 participants in 1 patient group

MOA-728 12 mg QD

Experimental group

Description:

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.

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)