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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: Completed Phase 3 study of Postoperative Pain and Hysterectomy, sponsored by Mallinckrodt.
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 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measureme
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
What the finished NCT00399568 record still lists
NCT00399568 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (45% higher).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for Postoperative 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 NCT00399568's enrollment target sits among peer trials
331 16th of 120 higher than 104 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative 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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