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Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Primary Purpose

Bowel Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SC MNTX
SC MNTX
SC MNTX
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Dysfunction focused on measuring Opioid-induced bowel dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
  2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
  3. Must have constipation
  4. Must be 18 yrs or older

Exclusion Criteria:

  1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
  2. Patients who received any experimental drug in the last 30 days
  3. Patients with active peritoneal cancer (ovarian, etc.)
  4. Patients with active diverticulitis or diverticulosis

Sites / Locations

  • Progenics Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects who have a bowel movement within four hours of dosing
To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Secondary Outcome Measures

Number of subject with Adverse Events
To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Full Information

First Posted
May 27, 2011
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01367574
Brief Title
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
Official Title
A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Dysfunction
Keywords
Opioid-induced bowel dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SC MNTX
Intervention Description
Dose 1
Intervention Type
Drug
Intervention Name(s)
SC MNTX
Intervention Description
Dose 2
Intervention Type
Drug
Intervention Name(s)
SC MNTX
Intervention Description
Dose 3
Primary Outcome Measure Information:
Title
Number of subjects who have a bowel movement within four hours of dosing
Description
To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Number of subject with Adverse Events
Description
To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen Must have constipation Must be 18 yrs or older Exclusion Criteria: Concurrent use of medications other than opioids which might interfere with gastrointestinal motility Patients who received any experimental drug in the last 30 days Patients with active peritoneal cancer (ovarian, etc.) Patients with active diverticulitis or diverticulosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tage Ramakrishna, MD
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
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

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Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

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