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Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

NCT00858754 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-11-29

No results posted yet for this study

Summary

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Conditions

  • Opioid-Induced Constipation

Interventions

DRUG

methylnaltrexone

DRUG

placebo

Sponsors & Collaborators

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Cohn · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Canada
  • France
  • Spain

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 NCT00858754 on ClinicalTrials.gov