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

Sponsor:	Cadence Pharmaceuticals
Information provided by:	Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00399568

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain Hysterectomy	Drug: IV Acetaminophen Drug: IV Placebo 100 mL solution	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:

Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo. [ Time Frame: Baseline (just prior to the first dose) through 24 hours ] [ Designated as safety issue: No ]
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.
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo [ Time Frame: Baseline (just prior to the first dose) through 48 hours ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: First dose through 7 day follow up ] [ Designated as safety issue: Yes ]
Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event. [ Time Frame: 32 days following first dose of study medication. ] [ Designated as safety issue: Yes ]
Number of subjects who reported SAEs during the study.

A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:

Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event

Enrollment:	331
Study Start Date:	November 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IV acetaminophen 1 g/100 mL solution	Drug: IV Acetaminophen Intravenous acetaminophen 1 g/100 mL Other Name: IV Acetaminophen (IV APAP)
Placebo Comparator: IV Placebo 100 mL solution	Drug: IV Placebo 100 mL solution IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h) Other Name: IV Placebo (non-active product)

Detailed Description:

The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
18-75 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399568

Locations

United States, Alabama
University of Alabama (Anesthesiology)
Birmingham, Alabama, United States, 35249
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center, Inc. (Arrowhead)
Phoenix, Arizona, United States, 85023
Arizona Research Center, Inc (JC Lincoln)
Phoenix, Arizona, United States, 85023
Precision Trials
Phoenix, Arizona, United States, 85032
United States, California
Arcadia Methodist Hospital
Arcadia, California, United States, 91007
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Huntington Memorial Hospital
Pasadena, California, United States, 91105
Accurate Clinical Trials, Inc.
San Clemente, California, United States, 92672
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33414
G and G Research, Inc.
Fort Pierce, Florida, United States, 34950
Century Clinical Research, INC
Holly Hill, Florida, United States, 32117
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
University of Miami School of Medicine Dept. of Anesthesiology
Miami, Florida, United States, 33136
Treasure Coast Obstetrics and Gynecology
Vero Beach, Florida, United States, 32960
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Cooper Anesthesia
Camden, New Jersey, United States, 08103
St. Peters University Hospital, Anesthesiology
New Brunswick, New Jersey, United States, 08901
United States, New York
Albany Medical College Dept. of Anesthesiology
Albany, New York, United States, 11208
Jacobi Medical Center (Albert Einstein College of Medicine)
Bronx, New York, United States, 10461
Weill Medical College
New York, New York, United States, 10021
Stony Brook Anesthesiology Health Sciences Cente
Stony Brook, New York, United States, 11794
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Allegheny Pain Managment
Altoona, Pennsylvania, United States, 16602
Thomas Jefferson University Dept. of Anesthesiology
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Memorial Herman/Memorial City Hospital
Houston, Texas, United States, 77024
Texas Woman's Hospital
Houston, Texas, United States, 77024

Sponsors and Collaborators

Cadence Pharmaceuticals

Investigators

Study Director:

Mike Royal, MD,JD,MBA

Cadence Pharmaceuticals

More Information

No publications provided

Responsible Party:	Mike Royal, MD, JD, MBA- Vice President Clinical Development-Analgesics, Cadence Pharmaceuticals,Inc.
ClinicalTrials.gov Identifier:	NCT00399568 History of Changes
Other Study ID Numbers:	CPI-APA-301
Study First Received:	November 14, 2006
Results First Received:	September 25, 2009
Last Updated:	December 9, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cadence Pharmaceuticals:

Pain
Gynecologic
IV Acetaminophen
Postoperative
Analgesic

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Analgesics
Antipyretics

Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012