Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
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ClinicalTrials.gov Identifier: NCT00605644 |
Recruitment Status
:
Completed
First Posted
: January 31, 2008
Last Update Posted
: July 28, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation | Drug: MOA-728 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Placebo
|
Experimental: 2
MOA-728
|
Drug: MOA-728
Oral Capsules
|
Experimental: 3
MOA-728
|
Drug: MOA-728
Oral Capsules
|
Experimental: 4
MOA-728
|
Drug: MOA-728
Oral Capsules
|
Experimental: 5
MOA-728
|
Drug: MOA-728
Oral Capsules
|
- Spontaneous Bowel Movements [ Time Frame: App. 1 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605644
Study Director: | Jeff Cohn | Valeant Pharmaceuticals International, Inc. |
Responsible Party: | Jeff Cohn, Salix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00605644 History of Changes |
Other Study ID Numbers: |
3200A3-2202 |
First Posted: | January 31, 2008 Key Record Dates |
Last Update Posted: | July 28, 2011 |
Last Verified: | July 2011 |
Additional relevant MeSH terms:
Constipation Signs and Symptoms, Digestive Signs and Symptoms |