ConstipationPhase 2NCT00366431
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
A Phase 2 study testing MOA-728 in people with Constipation, run by Bausch Health Americas, Inc. at 67 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- MOA-728
- How many people
- 420 participants
- Where
- 67 sitesUnited States
- Study dates
- Aug 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Alexandria, Virginia, 22304
Study site
Anaheim, California, 92801
Study site
Anaheim, California, 92805
Study site
Bakersfield, California, 93311
Study site
Beaumont, Texas, 77701
Study site
Birmingham, Alabama, 35215
Study site
Birmingham, Alabama, 35244
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Bloomington, Illinois, 61701
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Boston, Massachusetts, 02115
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Brockton, Massachusetts, 02301
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Charlotte, North Carolina, 28210
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60610
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Christiansburg, Virginia, 24073
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45224
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Clinton, Oklahoma, 73601
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Colleyville, Texas, 76034
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Dawsonville, Georgia, 30534
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Dayton, Ohio, 45439
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Elkridge, Maryland, 21075
Study site
Foothill Ranch, California, 92610
Study site
Garden Grove, California, 92843
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Great Neck, New York, 11023
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Haddon Heights, New Jersey, 08035
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Hollywood, Florida, 33021
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Hot Springs, Arkansas, 71913
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Independence, Missouri, 64055
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Indianapolis, Indiana, 46250
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Jacksonville, Florida, 32216
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Jupiter, Florida, 33458
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Lake Success, New York, 11042
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Largo, Florida, 33770
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Los Gatos, California, 95032
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Marietta, Georgia, 30060
Study site
Marietta, Georgia, 30066
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Miami, Florida, 33173
Study site
Miami, Florida, 33180
Study site
Missoula, Montana, 59808
Study site
Mobile, Alabama, 36608
Study site
Norfolk, Virginia, 23502
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Ocala, Florida, 34471
Study site
Omaha, Nebraska, 68114
Study site
Orange, California, 92869
Study site
Ormond Beach, Florida, 32174
Study site
Phoenix, Arizona, 85029
Study site
Picayune, Mississippi, 39466
Study site
Reno, Nevada, 89502
Study site
Richmond, Virginia, 23229
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Sacramento, California, 95831
Study site
Saginaw, Michigan, 48602
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Saint Cloud, Florida, 34769
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San Antonio, Texas, 78205
Study site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78238
Study site
San Diego, California, 92108
Study site
San Diego, California, 92120
Study site
San Diego, California, 92121
Study site
Tampa, Florida, 33607
Study site
Traverse City, Michigan, 49684
Study site
Trumbull, Connecticut, 06611
Study site
Tucson, Arizona, 85710
Study site
Tucson, Arizona, 85712
Study site
Tucson, Arizona, 85741
Study site
West Palm Beach, Florida, 33401
Study site
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Constipation
- Being tested
- MOA-728
- Keywords
- OIBD, OIC, Opioid, Constipation, Laxative
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOA-728Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startAug 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeff Cohn, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366431
- Sponsor's protocol ID
- 3200A3-200
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2006
- Last updated
- 25 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00366431
- Acronym / sponsor ID
- 3200A3-200
- Conditions
- Constipation
- Keywords
- OIBD, OIC, Opioid, Constipation, Laxative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOA-728 | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Cohn study director
Bausch Health Americas, Inc.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MOA-728 in people with Constipation, run by Bausch Health Americas, Inc. at 67 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.