- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00529087
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
November 21, 2019 updated by: Bausch Health Americas, Inc.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
460
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Mobile, Alabama, United States, 36608
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Mobile, Alabama, United States, 36606
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Arizona
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Sun City, Arizona, United States, 85351
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Tucson, Arizona, United States, 85741
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Tucson, Arizona, United States, 85710
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Arkansas
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Hot Springs, Arkansas, United States, 71913
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California
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Anaheim, California, United States, 92801
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Garden Grove, California, United States, 92843
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Hawaiian Gardens, California, United States, 90716
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Long Beach, California, United States, 90813
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Los Angeles, California, United States, 90048
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San Diego, California, United States, 92121
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Florida
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Brandon, Florida, United States, 33511
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Cheifland, Florida, United States, 32626
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Clearwater, Florida, United States, 33756
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Gainesville, Florida, United States, 32607
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Jacksonville, Florida, United States, 32216
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Jupiter, Florida, United States, 33458
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Largo, Florida, United States, 33770
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Miami, Florida, United States, 33180
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Naples, Florida, United States, 34104
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Ocala, Florida, United States, 34474
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32806
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Ormond Beach, Florida, United States, 32174
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Spring Hill, Florida, United States, 34609
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Tampa, Florida, United States, 33603
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West Palm Beach, Florida, United States, 33409
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Winter Park, Florida, United States, 32789
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Georgia
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Atlanta, Georgia, United States, 30329
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Marietta, Georgia, United States, 30060
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Stockbridge, Georgia, United States, 30281
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Illinois
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Chicago, Illinois, United States, 60610
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DeKalb, Illinois, United States, 60115
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Indiana
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Avon, Indiana, United States, 46123
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Indianapolis, Indiana, United States, 46250
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Iowa
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West Des Moines, Iowa, United States, 50265
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Louisiana
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Shreveport, Louisiana, United States, 71105
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Sunset, Louisiana, United States, 70584
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Maryland
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Elkridge, Maryland, United States, 21075
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Massachusetts
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Boston, Massachusetts, United States, 02115
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Brockton, Massachusetts, United States, 02301
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Michigan
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Cadillac, Michigan, United States, 49601
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Paw Paw, Michigan, United States, 49079
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Traverse City, Michigan, United States, 49684
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Mississippi
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Biloxi, Mississippi, United States, 39531
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Ocean Springs, Mississippi, United States, 39564
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Missouri
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Nixa, Missouri, United States, 65719
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Montana
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Kalispell, Montana, United States, 59901
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Missoula, Montana, United States, 59808
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Nebraska
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Omaha, Nebraska, United States, 68114
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Nevada
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Las Vegas, Nevada, United States, 89119
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New Mexico
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Albuquerque, New Mexico, United States, 87102
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New York
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Great Neck, New York, United States, 11023
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Valley Stream, New York, United States, 11580
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North Carolina
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Charlotte, North Carolina, United States, 28204
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Raleigh, North Carolina, United States, 27607-6475
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Dayton, Ohio, United States, 45439
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Toledo, Ohio, United States, 43623
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
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Oregon
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Medford, Oregon, United States, 97504
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Portland, Oregon, United States, 97210
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Pennsylvania
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Levittown, Pennsylvania, United States, 19056-2404
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Texas
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Austin, Texas, United States, 78705
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Beaumont, Texas, United States, 77701
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Colleyville, Texas, United States, 76034
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75251
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78209
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Virginia
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Alexandria, Virginia, United States, 22304
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Christiansburg, Virginia, United States, 24073
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Hampton, Virginia, United States, 23666
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Washington
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Spokane, Washington, United States, 99204
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Spokane, Washington, United States, 99208
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West Virginia
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Charleston, West Virginia, United States, 25304-1965
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
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Subcutaneous
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Placebo Comparator: 1
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placebo
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Experimental: 3
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Subcutaneous
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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up to 4 hours
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to the First Rescue-free Bowel Movement (RFBM) After First Dose
Time Frame: up to 24 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).
Responses following first injection were censored at 24 hours or at time of the second injection, which ever occurred first.
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up to 24 hours
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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
|
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.
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Baseline and 4 weeks
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Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)
Time Frame: 8 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 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.
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8 weeks
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Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in 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 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.
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4 weeks
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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
|
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.
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Within 1-6 hours during 4 week double-blind period
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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
|
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).
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Within 1-6 hours during 4-week double-blind period
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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
|
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.
|
4 weeks
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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
|
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.
|
Baseline and 4 weeks
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Change in Weekly Number of Bowel Movements During Double-blind Period
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)
Time Frame: 4 weeks
|
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).
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4 weeks
|
Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)
Time Frame: 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).
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.
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4 weeks
|
Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)
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).
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.)
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4 weeks
|
Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During 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).
The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.
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4 weeks
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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
|
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.)
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
4 weeks
|
Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.
Time Frame: weeks 5-12
|
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.
|
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
|
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.
|
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
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. Erratum In: Drugs Aging. 2021 Apr 23;:
- Michna 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 11, 2007
First Submitted That Met QC Criteria
September 11, 2007
First Posted (Estimate)
September 14, 2007
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Signs and Symptoms, Digestive
- Narcotic-Related Disorders
- Constipation
- Opioid-Induced Constipation
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Anticonvulsants
- Bromides
- Methylnaltrexone
Other Study ID Numbers
- 3200K1-3356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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