ConstipationPhase 3NCT00529087
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
A Phase 3 study testing N-methylnaltrexone bromide (MOA-728) in people with Constipation, run by Bausch Health Americas, Inc. at 78 sites in United States.
Trial summary
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC). 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
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 78 sitesUnited States
- Study dates
- Aug 2007to Dec 2008
- 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
- Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
- 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
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Alexandria, Virginia, 22304
Study site
Anaheim, California, 92801
Study site
Atlanta, Georgia, 30329
Study site
Austin, Texas, 78705
Study site
Avon, Indiana, 46123
Study site
Beaumont, Texas, 77701
Study site
Biloxi, Mississippi, 39531
Study site
Boston, Massachusetts, 02115
Study site
Brandon, Florida, 33511
Study site
Brockton, Massachusetts, 02301
Study site
Cadillac, Michigan, 49601
Study site
Charleston, West Virginia, 25304-1965
Study site
Charlotte, North Carolina, 28204
Study site
Chattanooga, Tennessee, 37404
Study site
Cheifland, Florida, 32626
Study site
Chicago, Illinois, 60610
Study site
Christiansburg, Virginia, 24073
Study site
Clearwater, Florida, 33756
Study site
Colleyville, Texas, 76034
Study site
Dallas, Texas, 75230
Study site
Dallas, Texas, 75251
Study site
Dayton, Ohio, 45439
Study site
DeKalb, Illinois, 60115
Study site
Elkridge, Maryland, 21075
Study site
Gainesville, Florida, 32607
Study site
Garden Grove, California, 92843
Study site
Great Neck, New York, 11023
Study site
Hampton, Virginia, 23666
Study site
Hawaiian Gardens, California, 90716
Study site
Hot Springs, Arkansas, 71913
Study site
Indianapolis, Indiana, 46250
Study site
Jacksonville, Florida, 32216
Study site
Jupiter, Florida, 33458
Study site
Kalispell, Montana, 59901
Study site
Largo, Florida, 33770
Study site
Las Vegas, Nevada, 89119
Study site
Levittown, Pennsylvania, 19056-2404
Study site
Long Beach, California, 90813
Study site
Los Angeles, California, 90048
Study site
Marietta, Georgia, 30060
Study site
Medford, Oregon, 97504
Study site
Miami, Florida, 33180
Study site
Missoula, Montana, 59808
Study site
Mobile, Alabama, 36606
Study site
Mobile, Alabama, 36608
Study site
Naples, Florida, 34104
Study site
Nixa, Missouri, 65719
Study site
Ocala, Florida, 34471
Study site
Ocala, Florida, 34474
Study site
Ocean Springs, Mississippi, 39564
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68114
Study site
Orlando, Florida, 32806
Study site
Ormond Beach, Florida, 32174
Study site
Paw Paw, Michigan, 49079
Study site
Portland, Oregon, 97210
Study site
Raleigh, North Carolina, 27607-6475
Study site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92121
Study site
Shreveport, Louisiana, 71105
Study site
Spokane, Washington, 99204
Study site
Spokane, Washington, 99208
Study site
Spring Hill, Florida, 34609
Study site
Stockbridge, Georgia, 30281
Study site
Sun City, Arizona, 85351
Study site
Sunset, Louisiana, 70584
Study site
Tampa, Florida, 33603
Study site
Toledo, Ohio, 43623
Study site
Traverse City, Michigan, 49684
Study site
Tucson, Arizona, 85710
Study site
Tucson, Arizona, 85741
Study site
Valley Stream, New York, 11580
Study site
West Des Moines, Iowa, 50265
Study site
West Palm Beach, Florida, 33409
Study site
Winston-Salem, North Carolina, 27103
Study site
Winter Park, Florida, 32789
About this study
Official title: A Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
- Conditions
- Constipation
- Being tested
- N-methylnaltrexone bromide (MOA-728), placebo
- Keywords
- Opioid-Induced Constipation
- Medical subject headings
- Constipation, Opioid-Induced 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
Subcutaneous
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Other: placebo |
| 2 | Experimental | Not described Receives: Drug: N-methylnaltrexone bromide (MOA-728) |
| 3 | 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 Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).
Measured: up to 4 hours
Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.
Measured: 4 weeks
Secondary outcomes (20)
Time to the First Rescue-free Bowel Movement (RFBM) After First Dose
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Responses following first injection were censored at 24 hours or at time of the second injection, which ever occurred first.
Measured: up to 24 hours
Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks
A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). The weekly number of RFBM was defined as the total number of RFBM reported during the double-blind period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.
Measured: Baseline and 4 weeks
Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBMs reported during study period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number. Weekly number of RFBM determined as missing for <4 days of information.
Measured: 8 weeks
Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBM reported during the study week divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.
Measured: 4 weeks
Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.
Measured: Within 1-6 hours during 4 week double-blind period
Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).
Measured: Within 1-6 hours during 4-week double-blind period
Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.
Measured: 4 weeks
Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.
Measured: Baseline and 4 weeks
Change in Weekly Number of Bowel Movements During Double-blind Period
Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The weekly number of BM was defined as the total number of BMs reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.
Measured: 4 weeks
Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)
RFBM defined as bowel movement with no laxatives during the prior 24 hours. Information on laxative use, bowel movements and assessments were reported daily by patient. Weekly number of quality RFBM was the total number of quality RFBM reported in study period divided by number of days with information and multiplied by 7 for a normalized weekly number. Stool quality assessed with the Bristol Stool Form Scale (7-points) (1=difficult to pass, 7=entirely liquid). A quality RFBM defined as one other than diarrhea (Bristol Type 1-5).
Measured: 4 weeks
Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)
A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). Weekly number of complete RFBM was the total number of complete RFBM reported in study period divided by the number of days with information, and multiplied by 7 for a normalized weekly number. A complete RFBM has a sensation of complete evacuation.
Measured: 4 weeks
Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)
Measured: 4 weeks
Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.
Measured: 4 weeks
Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)
Measured: 8 weeks
Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.
Measured: 8 weeks
Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1=separate hard lumps like nuts (difficult to pass) and Type 7=watery, no solid pieces (entirely liquid.) Specifically, Type 3=like a sausage but with cracks on the surface, Type 4=Like a sausage or snake, smooth and soft.
Measured: 4 weeks
Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.
Measured: 4 weeks
Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.
Measured: weeks 5-12
Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none, 1 = mild and 4=very severe.
Measured: 4 weeks
Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). A complete RFBM has a sensation of complete evacuation.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 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.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeff Cohn, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529087
- Sponsor's protocol ID
- 3200K1-3356
- Status last verified
- Nov 2019
- First submitted
- 11 Sep 2007
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
PubMed 33788162Michna E, Weil AJ, Duerden M, Schulman S, Wang W, Tzanis E, Zhang H, Yu D, Manley A, Randazzo B. Efficacy of subcutaneous methylnaltrexone in the treatment of opioid-induced constipation: a responder post hoc analysis. Pain Med. 2011 Aug;12(8):1223-30. doi: 10.1111/j.1526-4637.2011.01189.x. Epub 2011 Aug 2.
PubMed 21810165
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 Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain
- ClinicalTrials.gov ID
- NCT00529087
- Acronym / sponsor ID
- 3200K1-3356
- Conditions
- Constipation
- Keywords
- Opioid-Induced Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 11 May 2010
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 subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: placebo |
| 2 | Experimental | Drug: N-methylnaltrexone bromide (MOA-728) |
| 3 | 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 constipation and chronic non-malignant pain.
- 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)Subcutaneous | Drug | 2, 3 |
| placeboplacebo | Other | 1 |
Primary outcome
Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose
Time frame: up to 4 hours
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).
Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period
Time frame: 4 weeks
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.
20 secondary outcomes
Time to the First Rescue-free Bowel Movement (RFBM) After First Dose
Time frame: up to 24 hours
Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks
Time frame: Baseline and 4 weeks
Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)
Time frame: 8 weeks
Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period
Time frame: 4 weeks
Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period
Time frame: Within 1-6 hours during 4 week double-blind period
Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period
Time frame: Within 1-6 hours during 4-week double-blind period
Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period
Time frame: 4 weeks
Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks
Time frame: Baseline and 4 weeks
Change in Weekly Number of Bowel Movements During Double-blind Period
Time frame: 4 weeks
Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)
Time frame: 4 weeks
Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)
Time frame: 4 weeks
Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)
Time frame: 4 weeks
Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period
Time frame: 4 weeks
Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period
Time frame: 8 weeks
Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period
Time frame: 8 weeks
Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period
Time frame: 4 weeks
Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period
Time frame: 4 weeks
Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.
Time frame: weeks 5-12
Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period
Time frame: 4 weeks
Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33788162Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
- Derived from this study: PubMed 21810165Michna E, Weil AJ, Duerden M, Schulman S, Wang W, Tzanis E, Zhang H, Yu D, Manley A, Randazzo B. Efficacy of subcutaneous methylnaltrexone in the treatment of opioid-induced constipation: a responder post hoc analysis. Pain Med. 2011 Aug;12(8):1223-30. doi: 10.1111/j.1526-4637.2011.01189.x. Epub 2011 Aug 2.
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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.
78 sites in 1 country: 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 78 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 78 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 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 11 May 2010). 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 Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose (time frame: up to 4 hours). The study lists 2 primary outcomes in all. 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 NCT00529087, which also lists 2 linked publications.
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.