Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: N-methylnaltrexone bromide (MOA-728); Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547586

3200A3-2201

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
• Taking oral, transdermal, intravenous, or subcutaneous opioids.
• Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion criteria

• History of chronic constipation before the initiation of opioid therapy.
• Other GI disorders known to affect bowel transit.
• Women who are pregnant, breast-feeding, or plan to become pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: placebo

150 mg

Experimental group

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)

300 mg

Experimental group

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)

450 mg

Experimental group

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)

600 mg

Experimental group

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)