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

August 8, 2020 updated by: Bausch Health Americas, Inc.

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 Nonmalignant Pain

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: 150 mg
MOA-728
Drug: MOA-728
Oral Capsules
Experimental: 300 mg
MOA-728
Drug: MOA-728
Oral Capsules
Experimental: 450 mg
MOA-728
Drug: MOA-728
Oral Capsules
Experimental: 600 mg
MOA-728
Drug: MOA-728
Oral Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

  • Study Director: Jeff Cohn, Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 18, 2008

First Posted (Estimate)

January 31, 2008

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200A3-2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Constipation

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe