Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Bowel Dysfunction Clinical Trial

Official title:

A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367574
• Other study ID #: MNTX 251
• Status: Completed
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: May 2003

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Drug:
• SC MNTX
Dose 1
• SC MNTX
Dose 2
• SC MNTX
Dose 3

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 4 weeks
Secondary	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.	Up to 4 weeks