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Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

NCT00640146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-09-04

Study results available
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Summary

The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.

Conditions

  • Opioid-induced Constipation

Interventions

DRUG

Methylnaltrexone bromide

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

DRUG

Placebo

Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-19
Primary Completion
2009-01-21
Completion
2009-01-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00640146 on ClinicalTrials.gov