Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01367574
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 3
• Duration (Months): 13
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Dysfunction	Drug: SC MNTX; Drug: SC MNTX; Drug: SC MNTX	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: May 1, 2003
• Actual Study Completion Date: May 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: SC MNTX; Dose 1
Experimental: Arm 2	Drug: SC MNTX; Dose 2
Experimental: Arm 3	Drug: SC MNTX; Dose 3

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01367574
• Other Study ID Numbers: MNTX 251
• First Posted: Jun 7, 2011
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by , ,: Opioid-induced bowel dysfunction
• Additional relevant MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation; Methylnaltrexone

Study Results

No Results Posted as of Nov 27, 2019