Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Phase 2

Completed

• Conditions: Bowel Dysfunction
• Interventions: Drug: SC MNTX

• Registration Number: NCT01367574
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	SC MNTX	-
Arm 1	SC MNTX	-
Arm 3	SC MNTX	-

Primary Outcome Measures

Name	Time	Method
Number of subjects who have a bowel movement within four hours of dosing	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.

Secondary Outcome Measures

Name	Time	Method
Number of subject with Adverse Events	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.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States