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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00399568
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : December 10, 2010
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Hysterectomy Drug: IV Acetaminophen Drug: IV Placebo 100 mL solution Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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 :
  1. Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: First dose through 7 day follow up ]
    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)

  2. Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event. [ Time Frame: 32 days following first dose of study medication. ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399568


Locations
Show Show 27 study locations
Sponsors and Collaborators
Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00399568    
Other Study ID Numbers: CPI-APA-301
First Posted: November 15, 2006    Key Record Dates
Results First Posted: December 10, 2010
Last Update Posted: October 21, 2016
Last Verified: September 2016
Keywords provided by Mallinckrodt:
Pain
Gynecologic
IV Acetaminophen
Postoperative
Analgesic
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Pharmaceutical Solutions
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics