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Safety of Subcutaneous Methylnaltrexone for 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 bromide
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:

  • Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
  • Is receiving opioids on a regular schedule, not just as needed to control pain.
  • Likely to continue to need treatment of OIC for the duration of participation in the study.

Exclusion Criteria:

  • Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
  • Currently using an opioid antagonist or partial antagonist.
  • Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylnaltrexone bromide

Arm Description

Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. 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.

Outcomes

Primary Outcome Measures

Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.
This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.

Secondary Outcome Measures

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
NCT00672139
Brief Title
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
Official Title
Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 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 is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylnaltrexone bromide
Arm Type
Experimental
Arm Description
Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. 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.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone bromide
Other Intervention Name(s)
Relistor
Primary Outcome Measure Information:
Title
Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.
Description
This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments. Is receiving opioids on a regular schedule, not just as needed to control pain. Likely to continue to need treatment of OIC for the duration of participation in the study. Exclusion Criteria: Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator. Currently using an opioid antagonist or partial antagonist. Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
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
Orange
State/Province
New Jersey
ZIP/Postal Code
07018
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
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
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
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Salix Investigational Site
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Salix Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Salix Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
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
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
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
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
Salix Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Salix Investigational Site
City
Berlin
ZIP/Postal Code
14089
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
Salix Investigational Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mexico City DF
ZIP/Postal Code
03600
Country
Mexico
Facility Name
Salix Investigational Site
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Salix Investigational Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Salix Investigational Site
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL53 0QJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

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