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NCT00564486 · ClinicalTrials.gov registry record · Phase 3
Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain
A Phase 3 study of Pain, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 244
- Enrollment target
- 17
- Study locations
NCT00564486: Completed Phase 3 study of Pain, sponsored by Mallinckrodt.
NCT00564486 is a Phase 3 study of Pain that has completed, run by Mallinckrodt. The registered enrollment target is 244 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (20% lower). The trial reports 17 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00564486, a Phase 3 study of Pain, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 244 participants
- Enrollment target
- 17
- Study locations
Study Summary
This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).
Primary Outcome
Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with "100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline w
Conditions Studied
Interventions
- DRUG IV Placebo
- DRUG IV Acetaminophen
Study Locations (17)
Florida
- Visions Clinical Research - Boynton Beach
- Nature Coast Clinical Research - Crystal River
- G and G Research, Inc. - Ft. Pierce
- Advanced Surgery Associates at Mercy Hospital - Miami
- University of Miami School of Medicine - Miami
California
- Methodist Hospital - Arcadia
- Glendale Adventist Medical Center - Glendale
- Physicians Clinical Research Corporation - Laguna Hills
- Huntington Memorial Hospital - Pasadena
Michigan
- William Beaumont Hospital (Royal Oak) - Royal Oak
- William Beaumont Hospital (Troy) - Royal Oak
Texas
- Memorial Herman/Memorial City Hospital - Houston
- Texas Woman's Hospital - Houston
Alabama
- Helen Keller Hospital - Sheffield
Arizona
- Precision Trials - Phoenix
New Jersey
- Cooper University Hospital - Camden
New York
- Staten Island University Hospital - Staten Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00564486 record still lists
NCT00564486 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which IV Placebo is the first listed.
NCT00564486 lists 17 locations in 8 states (Florida, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT00564486 about?
NCT00564486 is a clinical study titled "Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain". This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy o...
What is the current status of trial NCT00564486?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 244 participants. The study started on 2007-11. Estimated completion is 2008-09.
What conditions does trial NCT00564486 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT00564486?
The interventions under investigation include: IV Placebo (DRUG), IV Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT00564486?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00564486 being conducted?
This trial has 17 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 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 NCT00564486's enrollment target sits among peer trials
244 75th of 374 higher than 299 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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