An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain

This study has been completed.
Sponsor:
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:
NCT00240864
First received: October 14, 2005
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extraction of at least three molars.


Condition Intervention Phase
Pain
Drug: placebo
Drug: acetaminophen
Drug: ibuprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain

Resource links provided by NLM:


Further study details as provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Primary Outcome Measures:
  • Time at which the proportion of subjects indicating non-zero pain relief for each active treatment becomes statistically significantly superior to placebo.

Secondary Outcome Measures:
  • Pain intensity differences from baseline and pain relief at each measurement time; Area under the curve of pain relief scores at1 hour (TOTPAR1); Pain intensity differences at 1 hour (SPID1); Subjects' global assessment of pain relief at one hour

Enrollment: 224
Study Completion Date: February 2004
Arms Assigned Interventions
Experimental: 001
acetaminophen
Drug: acetaminophen
Experimental: 002
ibuprofen
Drug: ibuprofen
Placebo Comparator: 003
placebo
Drug: placebo

Detailed Description:

The primary objective of this randomized, double-blind, placebo-controlled study is to determine the onset of analgesia following the administration of a single dose of 1000 mg of acetaminophen, 400 mg of ibuprofen or placebo in subjects experiencing acute postoperative dental pain secondary to the surgical extraction of at least three molars, with at least one being a partial or complete bony mandibular third molar impaction. After reporting moderate to severe pain following dental surgery, subjects record their baseline pain intensity and are treated with a single oral dose of acetaminophen, ibuprofen, or placebo. Subjects evaluate their pain intensity and pain relief relative to baseline at various timepoints up to 4 hours after taking study medication. Pain intensity is assessed using a five-point scale consisting of none (0), mild (1), moderate (2), moderately severe (3), and severe (4). Pain relief from baseline is evaluated on a five-point scale consisting of none (0), a little (1), some (2), a lot (3), and complete (4). At the end of the first hour of the observation period or at the time of taking supplemental analgesic medication (rescue treatment), whichever occurs first, subjects make an overall (global) assessment of the study medication, based on a five-point scale consisting of poor (0), fair (1), good (2), very good (3), or excellent (4). Subjects are required to remain at the study site for the duration of the four-hour observation period. The primary efficacy assessments are pain intensity differences from baseline and pain relief at each measurement time. Safety is assessed by monitoring adverse events occuring throughout the study. The primary hypotheses are that there is a difference between acetaminophen and placebo and between ibuprofen and placebo at some time point for the proportion of subjects reporting non-zero pain relief. The patients receive a single oral dose of one of the following three treatments: Two acetaminophen 500 mg caplets and two placebo ibuprofen capsules, two placebo acetaminophen caplets and two ibuprofen 200 mg capsules, or two placebo acetaminophen caplets and two placebo ibuprofen capsules.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indicates moderate to severe pain following the extraction of at least three molars (including at least one partial or complete bony mandibular third molar impaction)
  • weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28
  • not taking any medications for anxiety, depression or schizophrenia
  • if female, not pregnant or breastfeeding

Exclusion Criteria:

  • Used ibuprofen or acetaminophen within 12 hours preceding surgery or any other pain relievers or anti-inflammatory drugs within 24 hours preceding surgery
  • have any gastrointestinal disease that would interfere with the absorption and excretion of study medications
  • unable to swallow the study medication whole
  • have any significant medical condition
  • have a history of adverse reactions to acetaminophen, ibuprofen or any anesthetic agent used in the extraction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240864

Sponsors and Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00240864     History of Changes
Other Study ID Numbers: CR002671
Study First Received: October 14, 2005
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:
postoperative dental pain
acetaminophen
ibuprofen

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Acetaminophen
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014