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NCT00605644 Clinical Trial

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

Constipation Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00605644
Other study ID # 3200A3-2202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2008
Est. completion date May 2008

Study information
Verified date August 2020
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• MOA-728
Oral Capsules
• Placebo
Placebo

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bausch Health Americas, Inc. Progenics Pharmaceuticals, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment 3 hours
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