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Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

NCT00672139 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2018-03-07

Study results available
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Summary

This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

Conditions

  • Opioid-Induced Constipation

Interventions

DRUG

Methylnaltrexone bromide

Sponsors & Collaborators

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Enoch Bortey · Bausch Health Americas, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-01-31
Completion
2013-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Portugal
  • United Kingdom

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 NCT00672139 on ClinicalTrials.gov