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

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

    • Alabama
      • Mobile, Alabama, United States, 36608
      • Mobile, Alabama, United States, 36606
    • Arizona
      • Sun City, Arizona, United States, 85351
      • Tucson, Arizona, United States, 85741
      • Tucson, Arizona, United States, 85710
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Anaheim, California, United States, 92801
      • Garden Grove, California, United States, 92843
      • Hawaiian Gardens, California, United States, 90716
      • Long Beach, California, United States, 90813
      • Los Angeles, California, United States, 90048
      • San Diego, California, United States, 92121
    • Florida
      • Brandon, Florida, United States, 33511
      • Cheifland, Florida, United States, 32626
      • Clearwater, Florida, United States, 33756
      • Gainesville, Florida, United States, 32607
      • Jacksonville, Florida, United States, 32216
      • Jupiter, Florida, United States, 33458
      • Largo, Florida, United States, 33770
      • Miami, Florida, United States, 33180
      • Naples, Florida, United States, 34104
      • Ocala, Florida, United States, 34474
      • Ocala, Florida, United States, 34471
      • Orlando, Florida, United States, 32806
      • Ormond Beach, Florida, United States, 32174
      • Spring Hill, Florida, United States, 34609
      • Tampa, Florida, United States, 33603
      • West Palm Beach, Florida, United States, 33409
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Atlanta, Georgia, United States, 30329
      • Marietta, Georgia, United States, 30060
      • Stockbridge, Georgia, United States, 30281
    • Illinois
      • Chicago, Illinois, United States, 60610
      • DeKalb, Illinois, United States, 60115
    • Indiana
      • Avon, Indiana, United States, 46123
      • Indianapolis, Indiana, United States, 46250
    • Iowa
      • West Des Moines, Iowa, United States, 50265
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
      • Sunset, Louisiana, United States, 70584
    • Maryland
      • Elkridge, Maryland, United States, 21075
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Brockton, Massachusetts, United States, 02301
    • Michigan
      • Cadillac, Michigan, United States, 49601
      • Paw Paw, Michigan, United States, 49079
      • Traverse City, Michigan, United States, 49684
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
      • Ocean Springs, Mississippi, United States, 39564
    • Missouri
      • Nixa, Missouri, United States, 65719
    • Montana
      • Kalispell, Montana, United States, 59901
      • Missoula, Montana, United States, 59808
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • Great Neck, New York, United States, 11023
      • Valley Stream, New York, United States, 11580
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Raleigh, North Carolina, United States, 27607-6475
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Dayton, Ohio, United States, 45439
      • Toledo, Ohio, United States, 43623
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056-2404
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Texas
      • Austin, Texas, United States, 78705
      • Beaumont, Texas, United States, 77701
      • Colleyville, Texas, United States, 76034
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75251
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78209
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Christiansburg, Virginia, United States, 24073
      • Hampton, Virginia, United States, 23666
    • Washington
      • Spokane, Washington, United States, 99204
      • Spokane, Washington, United States, 99208
    • West Virginia
      • Charleston, West Virginia, United States, 25304-1965

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
Subcutaneous
Placebo Comparator: 1
placebo
Experimental: 3
Subcutaneous

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).
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
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.
4 weeks

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.
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
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.
Baseline and 4 weeks
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.
8 weeks
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.
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
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.
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
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).
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
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
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
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).
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.
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.)
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.
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
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.

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.

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

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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