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Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

NCT01367574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-11-27

No results posted yet for this study

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.

Conditions

  • Bowel Dysfunction

Interventions

DRUG

SC MNTX

Dose 1

DRUG

SC MNTX

Dose 2

DRUG

SC MNTX

Dose 3

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Tage Ramakrishna, MD · Progenics Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2003-05-31
Completion
2003-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367574 on ClinicalTrials.gov