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NCT00399568 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

A Phase 3 study of Postoperative Pain and Hysterectomy, sponsored by Mallinckrodt.

Completed
Registry status
Phase 3
Development phase
331
Enrollment target
20
Study locations

NCT00399568 is a Phase 3 study of Postoperative Pain and Hysterectomy that has completed, run by Mallinckrodt. The registered enrollment target is 331 participants, above the 226-participant average among 63 other Postoperative Pain trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT00399568, a Phase 3 study of Postoperative Pain and Hysterectomy, has completed, sponsored by Mallinckrodt.

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

Study Summary

This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

Interventions

  • DRUG IV Acetaminophen
  • DRUG IV Placebo 100 mL solution

Study Locations (20)

Florida

  • Visions Clinical Research - Boynton Beach
  • G and G Research, Inc. - Ft. Pierce
  • Century Clinical Research, INC - Holly Hill
  • Nature Coast Clinical Research - Inverness
  • University of Miami School of Medicine Dept. of Anesthesiology - Miami
  • Treasure Coast Obstetrics and Gynecology - Vero Beach

California

  • Arcadia Methodist Hospital - Arcadia
  • Glendale Adventist Medical Center - Glendale
  • Huntington Memorial Hospital - Pasadena
  • Accurate Clinical Trials, Inc. - San Clemente

Arizona

  • Arizona Research Center, Inc (JC Lincoln) - Phoenix
  • Arizona Research Center, Inc. (Arrowhead) - Phoenix
  • Precision Trials - Phoenix

Alabama

  • University of Alabama (Anesthesiology) - Birmingham
  • Helen Keller Hospital - Sheffield

New Jersey

  • Cooper Anesthesia - Camden
  • St. Peters University Hospital, Anesthesiology - New Brunswick

New York

  • Albany Medical College Dept. of Anesthesiology - Albany
  • Weill Medical College - New York

Michigan

  • William Beaumont Hospital - Royal Oak

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2006-11
Est. Completion 2007-09
Phase Phase 3

Sponsor

Mallinckrodt

69 total trials

What the Registry Record Tells You About NCT00399568

The ClinicalTrials.gov registry entry for NCT00399568 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 226-participant average among 63 other Postoperative Pain trials with a reported enrollment target (46% higher). The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which IV Acetaminophen is the first listed.

NCT00399568 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT00399568 about?

NCT00399568 is a clinical study titled "Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery". This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

What is the current status of trial NCT00399568?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2006-11. Estimated completion is 2007-09.

What conditions does trial NCT00399568 study?

This clinical trial studies the following conditions: Postoperative Pain, Hysterectomy.

What interventions are being tested in trial NCT00399568?

The interventions under investigation include: IV Acetaminophen (DRUG), IV Placebo 100 mL solution (DRUG).

Who is sponsoring clinical trial NCT00399568?

This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00399568 being conducted?

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