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NCT00226395 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Acute Pain, sponsored by Endo Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
320
Enrollment target
20
Study locations

NCT00226395: Completed Phase 3 study of Acute Pain, sponsored by Endo Pharmaceuticals.

NCT00226395 is a Phase 3 study of Acute Pain that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 320 participants, above the 262-participant average among 50 other Acute Pain trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00226395, a Phase 3 study of Acute Pain, has completed, sponsored by Endo Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
320 participants
Enrollment target
20
Study locations

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
Endo Pharmaceuticals

23 total trials

What the finished NCT00226395 record still lists

NCT00226395 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 262-participant average among 50 other Acute Pain trials with a reported enrollment target (22% higher).

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.

NCT00226395 names 20 study sites across 8 states, led by Alabama, Arizona, California.

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.

What interventions are being tested in trial NCT00226395?

The interventions under investigation include: Oxymorphone immediate release (DRUG).

Who is sponsoring clinical trial NCT00226395?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Acute Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00226395's enrollment target sits among peer trials

320 9th of 50 higher than 42 of 50 other Acute Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00226395, the US trial registry maintained by the National Library of Medicine. NCT00226395 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.