Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: MOA-728; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605644

3200A3-2202

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 administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Enrollment: 128 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: Triple Blind

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128 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

150 mg

Experimental group

Description:

MOA-728

Treatment:

Drug: MOA-728

300 mg

Experimental group

Description:

MOA-728

Treatment:

Drug: MOA-728

450 mg

Experimental group

Description:

MOA-728

Treatment:

Drug: MOA-728

600 mg

Experimental group

Description:

MOA-728

Treatment:

Drug: MOA-728