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NCT00672139 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Opioid-induced Constipation, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 4
Development phase
156
Enrollment target
20
Study locations

NCT00672139 is a Phase 4 study of Opioid-induced Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 156 participants, below the 7,201-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00672139, a Phase 4 study of Opioid-induced Constipation, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 4
Development phase
156 participants
Enrollment target
20
Study locations

Study 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 Studied

Opioid-induced Constipation

Interventions

  • DRUG Methylnaltrexone bromide

Study Locations (20)

Florida

  • Salix Investigational Site - Auburndale
  • Salix Investigational Site - Hudson
  • Salix Investigational Site - Lakeland
  • Salix Investigational Site - Lakeland
  • Salix Investigational Site - Miami Springs
  • Salix Investigational Site - Ruskin
  • Salix Investigational Site - Sebring
  • Salix Investigational Site - Tampa
  • Salix Investigational Site - Tampa
  • Salix Investigational Site - Tampa
  • Salix Investigational Site - Temple Terrace

California

  • Salix Investigational Site - Laguna Hills
  • Salix Investigational Site - Lancaster

North Carolina

  • Salix Investigational Site - Flat Rock
  • Salix Investigational Site - Winston-Salem

Alabama

  • Salix Investigational Site - Mobile

Colorado

  • Salix Investigational Site - Aurora

New Jersey

  • Salix Investigational Site - Orange

Ohio

  • Salix Investigational Site - Cleveland

Pennsylvania

  • Salix Investigational Site - Philadelphia

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2008-07
Est. Completion 2013-05
Phase Phase 4

Sponsor

Bausch Health Americas

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00672139

The ClinicalTrials.gov registry entry for NCT00672139 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,201-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (98% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 1 intervention - of which Methylnaltrexone bromide is the first listed.

NCT00672139 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00672139 about?

NCT00672139 is a clinical study titled "Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness". 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 stu...

What is the current status of trial NCT00672139?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 156 participants. The study started on 2008-07. Estimated completion is 2013-05.

What conditions does trial NCT00672139 study?

This clinical trial studies the following conditions: Opioid-induced Constipation.

What interventions are being tested in trial NCT00672139?

The interventions under investigation include: Methylnaltrexone bromide (DRUG).

Who is sponsoring clinical trial NCT00672139?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00672139 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.