Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Non-Malignant Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366431

Enrollment

420

Registered

2006-08-21

Start date

2006-08-31

Completion date

2007-03-31

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

OIBD, OIC, Opioid, Constipation, Laxative

Brief summary

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

Interventions

DRUGMOA-728

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain. * Taking oral, transdermal, intravenous, or subcutaneous opioids. * Willingness to discontinue all pre-study laxative therapy and utilize 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.

Design outcomes

Primary

Measure	Time frame
The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026