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COMPLETEDPhase 2NCT01367574

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 c...

Lead sponsor: Bausch Health Americas, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Bausch Health Americas, Inc.

Age

18 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 27, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment39

Start dateApr 2002

Last updatedNov 27, 2019

Condition

Bowel Dysfunction

Locations shown

Progenics Pharmaceuticals, Inc.

Tarrytown, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2019Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions