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

June 18, 2015 updated by: Johnson & Johnson Consumer and Personal Products Worldwide

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
acetaminophen
Drug: acetaminophen
Experimental: 002
ibuprofen
Drug: ibuprofen
Placebo Comparator: 003
placebo
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Collaborators

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 18, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002671

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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