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

February 7, 2018 updated by: Bausch Health Americas, Inc.

Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

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

  • Australia
      • Adelaide, Australia, 5000
        • Salix Investigational Site
    • Victoria
      • Coburg, Victoria, Australia, 3058
        • Salix Investigational Site
      • East Melbourne, Victoria, Australia, 3002
        • Salix Investigational Site
  • Belgium
      • Leuven, Belgium, B-3000
        • Salix Investigational Site
  • Canada
      • Quebec, Canada, G1R 3S1
        • Salix Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Salix Investigational Site
      • Edmonton, Alberta, Canada, T6L 5X8
        • Salix Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1W9
        • Salix Investigational Site
      • London, Ontario, Canada, N6A 4L6
        • Salix Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Salix Investigational Site
  • France
      • Montpellier, France, 34295
        • Salix Investigational Site
  • Germany
      • Berlin, Germany, 14089
        • Salix Investigational Site
  • Italy
      • L'Aquila, Italy, 67100
        • Salix Investigational Site
      • Milan, Italy, 20020
        • Salix Investigational Site
      • Milano, Italy, 20133
        • Salix Investigational Site
      • Roma, Italy, 00144
        • Salix Investigational Site
  • Mexico
      • Mexico City DF, Mexico, 03600
        • Pfizer Investigational Site
  • Portugal
      • Almada, Portugal, 2801-951
        • Salix Investigational Site
      • Porto, Portugal, 4200-072
        • Salix Investigational Site
  • United Kingdom
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 0Qj
        • Salix Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Salix Investigational Site
    • California
      • Laguna Hills, California, United States, 92637
        • Salix Investigational Site
      • Lancaster, California, United States, 93534
        • Salix Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Salix Investigational Site
    • Florida
      • Auburndale, Florida, United States, 33823
        • Salix Investigational Site
      • Hudson, Florida, United States, 34667
        • Salix Investigational Site
      • Lakeland, Florida, United States, 33805
        • Salix Investigational Site
      • Lakeland, Florida, United States, 33815
        • Salix Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Salix Investigational Site
      • Ruskin, Florida, United States, 33573
        • Salix Investigational Site
      • Sebring, Florida, United States, 33870
        • Salix Investigational Site
      • Tampa, Florida, United States, 33609
        • Salix Investigational Site
      • Tampa, Florida, United States, 33612-9416
        • Salix Investigational Site
      • Tampa, Florida, United States, 33619
        • Salix Investigational Site
      • Temple Terrace, Florida, United States, 33617
        • Salix Investigational Site
    • New Jersey
      • Orange, New Jersey, United States, 07018
        • Salix Investigational Site
    • North Carolina
      • Flat Rock, North Carolina, United States, 28731
        • Salix Investigational Site
      • Winston-Salem, North Carolina, United States, 27103-5766
        • Salix Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44119
        • Salix Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Salix Investigational Site
    • Texas
      • Austin, Texas, United States, 78757
        • Salix Investigational Site
      • Houston, Texas, United States, 77030
        • Salix Investigational Site
    • Utah
      • American Fork, Utah, United States, 84003
        • Salix Investigational Site
      • Orem, Utah, United States, 84058
        • Salix Investigational Site
      • Provo, Utah, United States, 84604
        • Salix Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Salix Investigational Site

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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylnaltrexone bromide

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.
Drug: Methylnaltrexone bromide
Other Names:
  • Relistor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.
Time Frame: 10 weeks
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

  • Study Director: Enoch Bortey, Bausch Health Americas, Inc.

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

July 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200K1-4001
  • B2541006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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