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Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

Primary Purpose

Opioid-Induced Constipation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Methylnaltrexone
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Induced Constipation focused on measuring opioid-induced constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is an adult 18 years of age or older
  • Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
  • Has a life expectancy of at least 1 month.
  • Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
  • Has constipation that is caused by opioid medications.

Exclusion Criteria:

  • Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
  • Has a known or suspected mechanical gastrointestinal obstruction.
  • Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
  • Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
  • Receiving opioid antagonist or partial antagonist products.

Sites / Locations

  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Pfizer Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylnaltrexone

Placebo

Arm Description

Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.

Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.

Outcomes

Primary Outcome Measures

The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.

Secondary Outcome Measures

Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.

Full Information

First Posted
May 2, 2008
Last Updated
February 7, 2018
Sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00672477
Brief Title
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Induced Constipation
Keywords
opioid-induced constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylnaltrexone
Arm Type
Experimental
Arm Description
Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone
Other Intervention Name(s)
MOA-728, Relistor
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
Description
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
Description
This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is an adult 18 years of age or older Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) Has a life expectancy of at least 1 month. Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug. Has constipation that is caused by opioid medications. Exclusion Criteria: Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone). Has a known or suspected mechanical gastrointestinal obstruction. Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation. Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study. Receiving opioid antagonist or partial antagonist products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enoch Bortey
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Salix Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Salix Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Salix Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Salix Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Salix Investigational Site
City
Auburndale
State/Province
Florida
ZIP/Postal Code
33823
Country
United States
Facility Name
Salix Investigational Site
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Salix Investigational Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Salix Investigational Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33815
Country
United States
Facility Name
Salix Investigational Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Salix Investigational Site
City
Ruskin
State/Province
Florida
ZIP/Postal Code
33573
Country
United States
Facility Name
Salix Investigational Site
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Facility Name
Salix Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Salix Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
Salix Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33619
Country
United States
Facility Name
Salix Investigational Site
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Salix Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Salix Investigational Site
City
Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Salix Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Salix Investigational Site
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
Salix Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-5766
Country
United States
Facility Name
Salix Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44119
Country
United States
Facility Name
Salix Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Salix Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Salix Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Salix Investigational Site
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Salix Investigational Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Salix Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Salix Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Salix Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Salix Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Salix Investigational Site
City
Coburg
State/Province
Victoria
ZIP/Postal Code
3058
Country
Australia
Facility Name
Salix Investigational Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Salix Investigational Site
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Salix Investigational Site
City
Liberdade
State/Province
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Salix Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01508-010
Country
Brazil
Facility Name
Salix Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Salix Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Salix Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1W9
Country
Canada
Facility Name
Salix Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Salix Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Salix Investigational Site
City
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
Salix Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Salix Investigational Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Salix Investigational Site
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Salix Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Salix Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Salix Investigational Site
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Salix Investigational Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Salix Investigational Site
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Salix Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Salix Investigational Site
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Salix Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Salix Investigational Site
City
Milan
ZIP/Postal Code
20020
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mexico City DF
ZIP/Postal Code
03600
Country
Mexico
Facility Name
Salix Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Salix Investigational Site
City
L'Hospitalet De Llobregat
ZIP/Postal Code
8097
Country
Spain
Facility Name
Salix Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Salix Investigational Site
City
Kungsbacka
ZIP/Postal Code
434 80
Country
Sweden
Facility Name
Salix Investigational Site
City
Norrköping
ZIP/Postal Code
60185
Country
Sweden
Facility Name
Salix Investigational Site
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL53 0Qj
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33788162
Citation
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;:
Results Reference
derived
PubMed Identifier
27573565
Citation
Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29. Erratum In: Ann Oncol. 2018 Apr 1;29(4):1076.
Results Reference
derived

Learn more about this trial

Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

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