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 Non-Malignant Pain
NCT number | NCT00366431 |
Other study ID # | 3200A3-200 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2006 |
Est. completion date | March 2007 |
Verified date | November 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 420 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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