ConstipationPhase 3NCT00804141

Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

A Phase 3 study testing N-methylnaltrexone bromide (MOA-728) in people with Constipation, run by Bausch Health Americas, Inc. at 120 sites in 6 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation
What is being tested?: N-methylnaltrexone bromide (MOA-728)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,040 participants
Where: 120 sitesin 6 countries
Study dates: 3 Dec 2008to 20 Sep 2010
Phase: Phase 3
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

Men and women 18 years or older.
A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
A history of constipation due to opioid use during 1 month before the screening visit.

Who cannot join

A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
A history of chronic constipation before initiation of opioid therapy.

Trial locations and contacts

120 sites in 6 countries.

Country

City, postcode or hospital

120 sites in 6 countries

United States94 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Avon, Indiana, 46123
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Bellevue, Washington, 98007
Pfizer Investigational Site
Biloxi, Mississippi, 39531
Pfizer Investigational Site
Bingham Farms, Michigan, 48025
Pfizer Investigational Site
Birmingham, Alabama, 35242
Pfizer Investigational Site
Boca Raton, Florida, 33432
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Brandon, Florida, 33511
Pfizer Investigational Site
Brockton, Massachusetts, 02301
Pfizer Investigational Site
Centerville, Ohio, 45459
Pfizer Investigational Site
Chandler, Arizona, 85224
Pfizer Investigational Site
Charlotte, North Carolina, 28204
Pfizer Investigational Site
Chesterfield, Michigan, 48047
Pfizer Investigational Site
Chicago, Illinois, 60616
Pfizer Investigational Site
Chiefland, Florida, 32626
Pfizer Investigational Site
Christiansburg, Virginia, 24073
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Colorado Springs, Colorado, 80904
Pfizer Investigational Site
Cranston, Rhode Island, 02920
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75234
Pfizer Investigational Site
Dayton, Ohio, 45432
Pfizer Investigational Site
Daytona Beach, Florida, 32117
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Elizabeth, New Jersey, 07202
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fort Myers, Florida, 33916
Pfizer Investigational Site
Gainesville, Florida, 32607
Pfizer Investigational Site
Garden Grove, California, 92843
Pfizer Investigational Site
Great Neck, New York, 11023
Pfizer Investigational Site
Hagerstown, Maryland, 21742
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Hollywood, Maryland, 20636
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Huntingdon, Tennessee, 38344
Pfizer Investigational Site
Hurst, Texas, 76054
Pfizer Investigational Site
Indianapolis, Indiana, 46205
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jacksonville, Florida, 32257
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Laguna Hills, California, 92653
Pfizer Investigational Site
Las Vegas, Nevada, 89119
Pfizer Investigational Site
Las Vegas, Nevada, 89123
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Levittown, Pennsylvania, 19056
Pfizer Investigational Site
Los Gatos, California, 95032
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Mesa, Arizona, 85206
Pfizer Investigational Site
Mesa, Arizona, 85213
Pfizer Investigational Site
Miami, Florida, 33180
Pfizer Investigational Site
Miami, Florida, 33183
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Ocala, Florida, 34471-2106
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Phoenix, Arizona, 85028
Pfizer Investigational Site
Phoenix, Arizona, 85029
Pfizer Investigational Site
Port Orange, Florida, 32129
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Raleigh, North Carolina, 27607
Pfizer Investigational Site
Rockford, Illinois, 61107
Pfizer Investigational Site
Salt Lake City, Utah, 84106
Pfizer Investigational Site
San Antonio, Texas, 78215
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Sarasota, Florida, 34231
Pfizer Investigational Site
Sarasota, Florida, 34239
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
Tampa, Florida, 33603
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
Traverse City, Michigan, 49684
Pfizer Investigational Site
Tucson, Arizona, 85710
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Vero Beach, Florida, 32960
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
West Des Moines, Iowa, 50265
Pfizer Investigational Site
Winter Park, Florida, 32789
Pfizer Investigational Site
Yardley, Pennsylvania, 19067

Other trials in United States

Canada17 sites

Pfizer Investigational Site
Dartmouth, Nova Scotia, B2Y 1H3
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8
Pfizer Investigational Site
Hamilton, Ontario, L8M 1K7
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 1Z9
Pfizer Investigational Site
London, Ontario, N5Y 5K7
Pfizer Investigational Site
Mirabel, Quebec, J7J 2K8
Pfizer Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 5B6
Pfizer Investigational Site
Oshawa, Ontario, L1H 7K4
Pfizer Investigational Site
Québec, Quebec, G2B 5S1
Pfizer Investigational Site
Saint Romuald, Quebec, G6W 5M6
Pfizer Investigational Site
Sainte-Foy, Quebec, G1W 4R4
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Trois-Rivières, Quebec, G8T 7A1
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1K3
Pfizer Investigational Site
Winnipeg, Manitoba, R2V 4W3

Other trials in Canada

South Korea4 sites

Pfizer Investigational Site
Seoul, Seoul/Korea, 138-736
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Colombia2 sites

Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca

Other trials in Colombia

Spain2 sites

Pfizer Investigational Site
Badalona, Barcelona/Spain, 08916
Pfizer Investigational Site
Madrid, Madrid/Spain, 28006

Other trials in Spain

Australia1 site

Pfizer Investigational Site
Broadmeadow, New South Wales, 2292

Other trials in Australia

About this study

Official title: An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain

This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.

Conditions: Constipation
Being tested: N-methylnaltrexone bromide (MOA-728)
Keywords: treatment for opioid-induced constipation
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
Also called Relistor
MOA-728 will be administered as per the dose and schedule specified in the arm.

Study groups in NCT00804141
Study group	Role	What they receive
MOA-728 12 mg QD	Experimental	Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day. Receives: Drug: N-methylnaltrexone bromide (MOA-728)

What is being measured

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline up to Week 50

Secondary outcomes (1)

Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up
Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing.
Measured: Baseline, follow-up (14 days [Week 49 to 50])

Timeline

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

3 Dec 200820 Sep 2010

First posted8 Dec 2008 (estimated)
Study start3 Dec 2008
Primary completion20 Sep 2010
Study completion20 Sep 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,040 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00804141
Sponsor's protocol ID: 3200K1-3358
Status last verified: Sep 2019
First submitted: 5 Dec 2008
Last updated: 18 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Michna E, Blonsky ER, Schulman S, Tzanis E, Manley A, Zhang H, Iyer S, Randazzo B. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011 May;12(5):554-62. doi: 10.1016/j.jpain.2010.11.008. Epub 2011 Mar 22.
PubMed 21429809

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
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
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain
ClinicalTrials.gov ID: NCT00804141
Acronym / sponsor ID: 3200K1-3358
Conditions: Constipation
Keywords: treatment for opioid-induced constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,040 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 3 Dec 2008 (actual)
Primary completion: 20 Sep 2010 (actual)
Study completion: 20 Sep 2010 (actual)
First posted: 8 Dec 2008 (estimated)
Results: Posted 18 Oct 2019

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MOA-728 12 mg QD	Experimental	Drug: N-methylnaltrexone bromide (MOA-728)Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men and women 18 years or older.
A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
A history of constipation due to opioid use during 1 month before the screening visit.

Key exclusion criteria (4 listed)

A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
A history of chronic constipation before initiation of opioid therapy.

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)Also: RelistorMOA-728 will be administered as per the dose and schedule specified in the arm.	Drug	MOA-728 12 mg QD

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 50
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

1 secondary outcome

Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up
Time frame: Baseline, follow-up (14 days [Week 49 to 50])

Results and safety

Results posted to the registry on 18 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MOA-728 12 mg QD	1,040	477

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Baseline up to Week 50. Count of participants. Unit: Participants

Measure	MOA-728 12 mg QD n = 1034
Any TEAEs	817
SAEs	104

Population analysed: All participants who received at least one dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to Week 50. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MOA-728 12 mg QD	104 of 1,034 (10.1%)	564 of 1,034 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21429809Michna E, Blonsky ER, Schulman S, Tzanis E, Manley A, Zhang H, Iyer S, Randazzo B. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011 May;12(5):554-62. doi: 10.1016/j.jpain.2010.11.008. Epub 2011 Mar 22.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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
IBS, Constipation Predominant, Anxiety State

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.

Lindsey Mathew study director

Bausch Health Americas, Inc.

120 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing N-methylnaltrexone bromide (MOA-728) in people with Constipation, run by Bausch Health Americas, Inc. at 120 sites in 6 countries.

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 4 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Canada, South Korea, Colombia, Spain and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Oct 2019). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 50). 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 NCT00804141, which also lists 1 linked publication.

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 18 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.