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NCT00804141 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

A Phase 3 study of Constipation, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
1,040
Enrollment target
20
Study locations

NCT00804141 is a Phase 3 study of Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 1,040 participants, above the 186-participant average among 54 other Constipation trials with a reported enrollment target (459% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT00804141, a Phase 3 study of Constipation, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
1,040 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.

Conditions Studied

Constipation

Interventions

  • DRUG N-methylnaltrexone bromide (MOA-728)

Study Locations (20)

Arizona

  • Pfizer Investigational Site - Chandler
  • Pfizer Investigational Site - Mesa
  • Pfizer Investigational Site - Mesa
  • Pfizer Investigational Site - Phoenix
  • Pfizer Investigational Site - Phoenix
  • Pfizer Investigational Site - Tempe
  • Pfizer Investigational Site - Tucson
  • Pfizer Investigational Site - Tucson

California

  • Pfizer Investigational Site - Garden Grove
  • Pfizer Investigational Site - Laguna Hills
  • Pfizer Investigational Site - Los Gatos
  • Pfizer Investigational Site - Newport Beach
  • Pfizer Investigational Site - Newport Beach

Florida

  • Pfizer Investigational Site - Boca Raton
  • Pfizer Investigational Site - Brandon
  • Pfizer Investigational Site - Chiefland
  • Pfizer Investigational Site - Clearwater

Alabama

  • Pfizer Investigational Site - Birmingham

Arkansas

  • Pfizer Investigational Site - Hot Springs

Colorado

  • Pfizer Investigational Site - Colorado Springs

Trial Details

FieldValue
Enrollment Target 1,040 participants
Start Date 2008-12-03
Est. Completion 2010-09-20
Phase Phase 3

Sponsor

Bausch Health Americas

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00804141

The ClinicalTrials.gov registry entry for NCT00804141 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,040 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 186-participant average among 54 other Constipation trials with a reported enrollment target (459% higher). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Constipation appearing as the primary indexed condition, and to 1 intervention - of which N-methylnaltrexone bromide (MOA-728) is the first listed.

NCT00804141 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Arizona, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00804141 about?

NCT00804141 is a clinical study titled "Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation". This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week...

What is the current status of trial NCT00804141?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,040 participants. The study started on 2008-12-03. Estimated completion is 2010-09-20.

What conditions does trial NCT00804141 study?

This clinical trial studies the following conditions: Constipation.

What interventions are being tested in trial NCT00804141?

The interventions under investigation include: N-methylnaltrexone bromide (MOA-728) (DRUG).

Who is sponsoring clinical trial NCT00804141?

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

Where is trial NCT00804141 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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.