- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01367574
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
November 26, 2019 updated by: Bausch Health Americas, Inc.
A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
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
-
-
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:
- 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
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
Dose 1
Dose 2
Dose 3
|
Experimental: Arm 2
|
Dose 1
Dose 2
Dose 3
|
Experimental: Arm 3
|
Dose 1
Dose 2
Dose 3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects who have a bowel movement within four hours of dosing
Time Frame: Up to 4 weeks
|
To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.
|
Up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subject with Adverse Events
Time Frame: Up to 4 weeks
|
To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.
|
Up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2002
Primary Completion (Actual)
May 1, 2003
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
May 27, 2011
First Submitted That Met QC Criteria
June 6, 2011
First Posted (Estimate)
June 7, 2011
Study Record Updates
Last Update Posted (Actual)
November 27, 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
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Substance-Related Disorders
- Signs and Symptoms, Digestive
- Narcotic-Related Disorders
- Constipation
- Gastrointestinal Diseases
- Intestinal Diseases
- Opioid-Induced Constipation
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Methylnaltrexone
Other Study ID Numbers
- MNTX 251
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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