Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
This study has been completed.
Sponsor:
Cadence Pharmaceuticals
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00399568
First received: November 14, 2006
Last updated: December 9, 2010
Last verified: December 2010
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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 3 |
| 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
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 May 22, 2013