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Compassionate Use Study of Methylnaltrexone

Primary Purpose

Opioid-induced Constipation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylnaltrexone
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

Eligibility Criteria

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

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.

Sites / Locations

  • Progenics Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylnaltrexone

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Opioid Induced Side Effects
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.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2011
Last Updated
August 12, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01368562
Brief Title
Compassionate Use Study of Methylnaltrexone
Official Title
A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 24, 2003 (Actual)
Primary Completion Date
June 2, 2008 (Actual)
Study Completion Date
June 2, 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylnaltrexone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone
Intervention Description
Methylnaltrexone will be administered as per the dose and schedule specified in the arm.
Primary Outcome Measure Information:
Title
Number of Participants With Opioid Induced Side Effects
Description
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.
Time Frame
From start of treatment until end of study (up to maximum 3.4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Bausch Health Companies
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc.
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Compassionate Use Study of Methylnaltrexone

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