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COMPLETED Phase 3

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

NCT00804141 · View on ClinicalTrials.gov ↗

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

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

55 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00804141 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00804141?

The interventions under investigation include: N-methylnaltrexone bromide (MOA-728) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00804141?

This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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