Compassionate Use Study of Methylnaltrexone

August 12, 2019 updated by: Bausch Health Americas, Inc.

A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects

This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

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

  • United States
    • New York
      • Tarrytown, New York, United States, 10591
        • Progenics Pharmaceuticals, Inc.

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:

  • Advanced medical illness (that is; terminal illness, such as incurable cancer or end stage aqcuired immunodeficiency syndrome [AIDS]) with a life expectancy of one to six months.
  • On an opioid regimen for the control of pain/discomfort for at least seven days.
  • Has opioid-induced constipation.
  • Stable vital signs and systolic blood pressure greater than or equal to (>=) 85 millimeters of mercury (mmHg), and diastolic blood pressure >=45 mmHg (Supine or sitting).
  • Females of childbearing potential must have a negative pregnancy test (serum or urine).
  • On a laxative regimen (for example, stool softener and SENNA or equivalent) for at least 3 days prior to treatment. Participants who have discontinued laxatives due to intolerability or lack of efficacy are also eligible.

Exclusion Criteria:

  • Participants with known hypersensitivity to methylnaltrexone, naltrexone or naloxone.
  • Participants who received any investigational new drug (experimental) except for methylnaltrexone in the previous 30 days.
  • Participants who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction.
  • Participants who are constipated and have active, clinically significant diverticulitis.
  • Participants with a surgically acute abdomen.
  • Participants being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure.
  • Individuals with a known drug addiction.
  • Females who are pregnant or nursing.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Methylnaltrexone
Participants will receive single dose of MNTX 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC). Subsequent dosing could be adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability.
Drug: Methylnaltrexone
Methylnaltrexone will be administered as per the dose and schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Opioid Induced Side Effects
Time Frame: From start of treatment until end of study (up to maximum 3.4 years)
Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
From start of treatment until end of study (up to maximum 3.4 years)

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

January 24, 2003

Primary Completion (ACTUAL)

June 2, 2008

Study Completion (ACTUAL)

June 2, 2008

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (ESTIMATE)

June 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNTX 901

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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