Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Constipation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529087

3200K1-3356

Details and patient eligibility

About

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
• 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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460 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Other: placebo

2

Experimental group

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)

3

Experimental group

Treatment:

Drug: N-methylnaltrexone bromide (MOA-728)