ConstipationPhase 2NCT00547586

Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

A Phase 2 study testing N-methylnaltrexone bromide (MOA-728) in people with Constipation, run by Bausch Health Americas, Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation
What is being tested?: N-methylnaltrexone bromide (MOA-728)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 41 sitesUnited States
Study dates: Oct 2007to Feb 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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.

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

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Study site
Albuquerque, New Mexico, 87102
Study site
Alexandria, Virginia, 22304
Study site
Beaumont, Texas, 77701
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Biloxi, Mississippi, 39531
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Brockton, Massachusetts, 2301
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Cadillac, Michigan, 49601
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Charlotte, North Carolina, 28204
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60610
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Chiefland, Florida, 32626
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Colleyville, Texas, 76034
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Dallas, Texas, 75230
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Dayton, Ohio, 45439
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Elkridge, Maryland, 21075
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Garden Grove, California, 92843
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Hot Springs, Arkansas, 71901
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Hot Springs, Arkansas, 71903
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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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Largo, Florida, 33770
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Las Vegas, Nevada, 89119
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Litchfield Park, Arizona, 85340
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Long Beach, California, 90813
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Los Angeles, California, 90048
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Medford, Oregon, 97504
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Mobile, Alabama, 36608
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Murrieta, California, 30060
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Naples, Florida, 34104
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Ocala, Florida, 34471
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Ocean Springs, Mississippi, 39564
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Ormond Beach, Florida, 32174
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San Antonio, Texas, 78229
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San Diego, California, 92121
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Spring Hill, Florida, 34609
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Sunset, Louisiana, 70584
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Toledo, Ohio, 43623
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Traverse City, Michigan, 49684
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Tucson, Arizona, 85710
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Tucson, Arizona, 85741
Study site
Winston-Salem, North Carolina, 27103

Other trials in United States

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 Nonmalignant Pain

Conditions: Constipation
Being tested: N-methylnaltrexone bromide (MOA-728), placebo
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-methylnaltrexone bromide (MOA-728)Drug
Oral
placeboOther
placebo

Study groups in NCT00547586
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Other: placebo
150 mg	Experimental	Not described Receives: Drug: N-methylnaltrexone bromide (MOA-728)
300 mg	Experimental	Not described Receives: Drug: N-methylnaltrexone bromide (MOA-728)
450 mg	Experimental	Not described Receives: Drug: N-methylnaltrexone bromide (MOA-728)
600 mg	Experimental	Not described Receives: Drug: N-methylnaltrexone bromide (MOA-728)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Feb 2008

First posted22 Oct 2007 (estimated)
Study startOct 2007
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00547586
Sponsor's protocol ID: 3200A3-2201
Status last verified: Aug 2020
First submitted: 19 Oct 2007
Last updated: 20 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. 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 Nonmalignant Pain
ClinicalTrials.gov ID: NCT00547586
Acronym / sponsor ID: 3200A3-2201
Conditions: Constipation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Collaborators: Progenics Pharmaceuticals, Inc.
Study start: Oct 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 22 Oct 2007 (estimated)
Results: Posted 20 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Placebo	Placebo comparator	Other: placebo
150 mg	Experimental	Drug: N-methylnaltrexone bromide (MOA-728)
300 mg	Experimental	Drug: N-methylnaltrexone bromide (MOA-728)
450 mg	Experimental	Drug: N-methylnaltrexone bromide (MOA-728)
600 mg	Experimental	Drug: N-methylnaltrexone bromide (MOA-728)

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 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.

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
N-methylnaltrexone bromide (MOA-728)Oral	Drug	150 mg, 300 mg, 450 mg, 600 mg
placeboplacebo	Other	Placebo

Primary outcome

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Time frame: 6 hours

Results and safety

Results posted to the registry on 20 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	33	28
150 mg	7	6
300 mg	14	13
450 mg	33	27
600 mg	35	32

Primary outcome: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment

Time frame: 6 hours. Count of participants. Unit: Participants

Measure	Placebo n = 33	150 mg n = 7	300 mg n = 14	450 mg n = 33	600 mg n = 35
Within 1 hour of 1st dose	0	0	0	7	2
Within 2 hours of 1st dose	1	1	1	9	5
Within 3 hours of 1st dose	3	1	2	13	9
Within 4 hours of 1st dose	3	1	4	15	14
Within 6 hours of 1st dose	6	1	4	15	17

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 33 (0%)	10 of 33 (30.3%)	15 of 33
150 mg	0 of 7 (0%)	3 of 7 (42.9%)	3 of 7
300 mg	0 of 14 (0%)	4 of 14 (28.6%)	4 of 14
450 mg	1 of 33 (3%)	9 of 33 (27.3%)	13 of 33
600 mg	3 of 35 (8.6%)	6 of 35 (17.1%)	18 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

41 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 N-methylnaltrexone bromide (MOA-728) in people with Constipation, run by Bausch Health Americas, Inc. at 41 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 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547586.

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 20 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.