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COMPLETED Phase 3

Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain

NCT00226395 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.

Conditions Studied

Interventions

  • DRUG Oxymorphone immediate release

Study Locations (20)

Alabama

  • Brookwood Medical Center — Birmingham
  • The Medical Center, Dept. Clinical research — Birmingham
  • Montgomery Women's Health Associates — Montgomery

Arizona

  • Arrowhead Community Hospital — Phoenix
  • John C Lincoln Hospital — Phoenix
  • Paradise Valley Hospital — Phoenix

California

  • Glendale Adventist Medical Center — Glendale
  • Saddleback Memorial Medical Center — Laguna Hills
  • Huntington Memorial Hospital — Pasadena

North Carolina

  • Duke University Medical Center — Durham
  • Forsyth Medical Center — Winston-Salem
  • Medical Park Hospital — Winston-Salem

Florida

  • Palm West Hospital — Palm Springs
  • Sacred Heart Hospital — Pensacola

Pennsylvania

  • Univ. Pittsburgh Hospital — Pittsburgh
  • Univ. Pittsburgh Medical center — Pittsburgh

Texas

  • Memorial Hermann Memorial City Hospital — Houston
  • The Methodist Hospital — Houston

Utah

  • Cottonwood Hospital — Salt Lake City
  • LDS Hospital — Salt Lake City

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2004-09
Est. Completion 2005-08
Phase Phase 3

Sponsor

Endo Pharmaceuticals

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00226395

The ClinicalTrials.gov registry entry for NCT00226395 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 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 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 Acute Pain appearing as the primary indexed condition, and to 1 intervention — of which Oxymorphone immediate release 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: NCT00226395 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Alabama, Arizona, California. 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 NCT00226395 about?

NCT00226395 is a clinical study titled "Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain". The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.

What is the current status of trial NCT00226395?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2004-09. Estimated completion is 2005-08.

What conditions does trial NCT00226395 study?

This clinical trial studies the following conditions: Acute Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00226395?

The interventions under investigation include: Oxymorphone immediate release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00226395?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00226395 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, North Carolina. 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