Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery
1 other identifier
interventional
331
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 postoperative-pain
Started Nov 2006
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedResults Posted
Study results publicly available
December 10, 2010
CompletedOctober 21, 2016
September 1, 2016
10 months
November 14, 2006
September 25, 2009
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
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 measurement is 0-2400 mm for 24 hours.
Baseline (just prior to the first dose) through 24 hours
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm 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 measurement is 0-4800 mm for 48 hours.
Baseline (just prior to the first dose) through 48 hours
Secondary Outcomes (2)
Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
First dose through 7 day follow up
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
32 days following first dose of study medication.
Study Arms (2)
IV acetaminophen 1 g/100 mL solution
EXPERIMENTALIV Placebo 100 mL solution
PLACEBO COMPARATORInterventions
Intravenous acetaminophen 1 g/100 mL
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Eligibility Criteria
You may qualify if:
- Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
- years of age
- Body Mass Index (BMI) between 19-45
- American Society of Anesthesiologists (ASA) risk class of I, II, III
- Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
- Moderate to Severe pain at rest
You may not qualify if:
- Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
- Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
- Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
- Known history of alcohol or drug abuse or misuse
- Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
- Has significant medical disease(s), or conditions that may contraindicate participation in the study
- Has participated in another clinical trial within 30 days of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (27)
University of Alabama (Anesthesiology)
Birmingham, Alabama, 35249, United States
Helen Keller Hospital
Sheffield, Alabama, 35660, United States
Arizona Research Center, Inc (JC Lincoln)
Phoenix, Arizona, 85023, United States
Arizona Research Center, Inc. (Arrowhead)
Phoenix, Arizona, 85023, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Arcadia Methodist Hospital
Arcadia, California, 91007, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Accurate Clinical Trials, Inc.
San Clemente, California, 92672, United States
Visions Clinical Research
Boynton Beach, Florida, 33414, United States
G and G Research, Inc.
Ft. Pierce, Florida, 34950, United States
Century Clinical Research, INC
Holly Hill, Florida, 32117, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
University of Miami School of Medicine Dept. of Anesthesiology
Miami, Florida, 33136, United States
Treasure Coast Obstetrics and Gynecology
Vero Beach, Florida, 32960, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Cooper Anesthesia
Camden, New Jersey, 08103, United States
St. Peters University Hospital, Anesthesiology
New Brunswick, New Jersey, 08901, United States
Albany Medical College Dept. of Anesthesiology
Albany, New York, 11208, United States
Weill Medical College
New York, New York, 10021, United States
Stony Brook Anesthesiology Health Sciences Cente
Stony Brook, New York, 11794, United States
Jacobi Medical Center (Albert Einstein College of Medicine)
The Bronx, New York, 10461, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Allegheny Pain Managment
Altoona, Pennsylvania, 16602, United States
Thomas Jefferson University Dept. of Anesthesiology
Philadelphia, Pennsylvania, 19107, United States
Memorial Herman/Memorial City Hospital
Houston, Texas, 77024, United States
Texas Woman's Hospital
Houston, Texas, 77024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lawrence Hill
- Organization
- Mallinckrodt Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
November 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
October 21, 2016
Results First Posted
December 10, 2010
Record last verified: 2016-09