Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

November 26, 2019 updated by: Bausch Health Americas, Inc.

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
  • France
      • Villejuif Cedex, France, 94804
        • Pfizer Investigational Site
  • Spain
    • Murcia/Spain
      • El Palmar, Murcia/Spain, Spain, 30120
        • Pfizer Investigational Site
  • United States
    • California
      • Laguna Hills, California, United States, 92637
        • Pfizer Investigational Site
      • Lancaster, California, United States, 93534
        • Pfizer Investigational Site
    • North Carolina
      • Flat Rock, North Carolina, United States, 28731
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer 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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is a man or woman aged 18 years or older.
  • Has a body weight >= 38 kg.
  • Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
  • Has a life expectancy of >= 6 months.
  • Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Is taking opioids for cancer-related pain, and not just as-needed doses.
  • Has a diagnosis of OIC as determined by the investigator.
  • Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria:

  • Has a history of chronic constipation before starting opioids.
  • Has renal disease receiving dialysis.
  • Has an ostomy for stools.
  • Is a pregnant or breastfeeding woman.

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: Group 1 Active Drug
Methylnaltrexone
Drug: methylnaltrexone
Other Names:
  • MOA-728
Placebo Comparator: Group 2 Non-Active Drug
Placebo
Drug: placebo
Other Names:
  • Inactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

Outcome Measure
Time Frame
1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.
Time Frame: 2 weeks
2 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: 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.

Helpful Links

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

March 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200K1-4006

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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