Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain

NCT00564486 | Completed Phase 3 Results

• 1 other identifier: CPI-APA-304
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 17

Brief 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).

Conditions

Pain

Keywords

Abdominal Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)

  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 was compared to the PI at each timepoint and differences were summed over the 24 hour time period.

  Baseline to 24 hrs

Secondary Outcomes (3)

• Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)

  Baseline to 24 hrs

• The Number of Subjects Reporting a Treatment Emergent Adverse Event

  First dose through 7 day follow up

• The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event

  First dose to 30 days after last dose of study medication.

Study Arms (4)

IV Placebo 100 ml

PLACEBO COMPARATOR

IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).

Drug: IV Placebo

IV Placebo 65 ml

PLACEBO COMPARATOR

IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).

Drug: IV Placebo

IV Acetaminophen 1 gm

EXPERIMENTAL

IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).

Drug: IV Acetaminophen

IV Acetaminophen 650 mg

EXPERIMENTAL

IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).

Drug: IV Acetaminophen

Interventions

IV Placebo DRUG

IV, every 6 hours for 24 hours (4 doses total)

Also known as: placebo

IV Placebo 100 ml

IV Acetaminophen DRUG

IV, every 6 hours for 24 hours (4 doses total)

Also known as: APAP, IV APAP

IV Acetaminophen 1 gm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written Informed Consent prior to participation in the Study
• Is scheduled to undergo abdominal laparoscopic surgery under general anesthesia (laparoscopic bariatric procedures, including gastric bypass or gastric banding, laparoscopic exploratory procedures in which no visceral dissection is performed, and laparoscopic procedures with minimal visceral dissection, such as laparoscopic sterilization,are excluded)
• If Subject is a female of childbearing potential, have a negative pregnancy test within 21 days of surgery
• Be at least 18, but not more than 80 years of age
• Have a Body Mass Index (BMI) ≥ 19 and ≤ 40 lb/in2
• Have an American Society of Anesthesiologist (ASA) risk class of I, II, or III
• Have the ability to read and understand the Study procedures and the use of the pain scales and have the ability to communicate meaningfully with the Study Investigator and staff
• Be free of other physical, mental, or medical conditions which, in the opinion of the Investigator, makes Study participation inadvisable

You may not qualify if:

• Used opioids or tramadol daily for greater than 7 days prior to Study Medication administration (Subjects who, in the Investigator's opinion have or are developing opioid tolerance are to be excluded)
• Has been treated with Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal, Skullcap, St. John's Wort, or Valerian within 14 days prior to surgery
• Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
• Has known hypersensitivity to opioids, acetaminophen, or the inactive ingredients (excipients) of the Study Medication
• Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years
• Has impaired liver function, e.g., aspartate aminotransferase (AST)/Alanine transaminase (ALT)/bilirubin greater than or equal to 3.0 times the upper limit of normal, active hepatic disease, evidence of clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with Study Medication exposure
• Has been treated with monoamine oxidase inhibitors (MAOIs) within 7 days prior to surgery
• Has participated in another clinical Study (investigational or marketed product) within 30 days of surgery
• The Subject must not meet any of the following criteria prior to randomization to Study Medication:
• Had any other surgery than the planned laparoscopic surgery or had intra operative or post operative complications which in the view of the Investigator would make Study participation inadvisable
• Has taken non steroidal anti-inflammatory drugs (NSAIDs), steroids or MAOIs during the day after surgery. Exceptions: The use of low-dose aspirin, e.g, 81 mg/day, for cardioprophylaxis, and limited use of topical or inhaled steroids are acceptable.
• Had any neuraxial (spinal or epidural) opioid injected perioperatively
• Had a local anesthetic injection (including into surgical wound at closure) or continuous infusion by any route
• Had an epidural, regional, or percutaneous (intrawound) catheter with continuous local anesthetic infusion used for postoperative analgesic management
• Had a fever (greater than 38.6 ºC or 101.5 ºF) requiring treatment

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (17)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Methodist Hospital

Arcadia, California, 91007, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Physicians Clinical Research Corporation

Laguna Hills, California, 92653, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33414, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

G and G Research, Inc.

Ft. Pierce, Florida, 34950, United States

Location

Advanced Surgery Associates at Mercy Hospital

Miami, Florida, 33133, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

William Beaumont Hospital (Royal Oak)

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital (Troy)

Royal Oak, Michigan, 48073, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Memorial Herman/Memorial City Hospital

Houston, Texas, 77024, United States

Location

Texas Woman's Hospital

Houston, Texas, 77024, United States

Location

Related Publications (1)

• Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.

  PMID: 21353105 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

One subject was randomized to receive IV APAP 1 g, but was administered IV APAP 650 mg. The subject was included in 1g IV APAP group for efficacy purposes and included in IV APAP 650 mg safety group for AE purposes.

Results Point of Contact

• Title: Lawrence Hill
• Organization: Mallinckrodt Pharmaceuticals

lawrence.hill@mallinckrodt.com

908-238-6370

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 28, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 21, 2016
• Results First Posted: November 30, 2010

Record last verified: 2016-09

Locations

US (17)