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

• ClinicalTrials.gov Identifier: NCT00240825
• Recruitment Status: Completed
• First Posted: October 18, 2005
• Last Update Posted: June 19, 2015
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Collaborator: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pain	Drug: Ibuprofen; Drug: Placebo; Drug: Acetaminophen	Phase 4

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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Actual Study Completion Date: February 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: 001; Acetaminophen	Drug: Acetaminophen
Experimental: 002; Ibuprofen	Drug: Ibuprofen
Placebo Comparator: 003; Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Pain intensity differences from baseline and pain relief at each measurement time; Area under the curve of pain relief scores at 1 hour (TOTPAR1); Pain intensity differences at 1 hour (SPID1); Subject's global assessment of pain relief at one hour

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

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:

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

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT00240825
• Other Study ID Numbers: CR002812
• First Posted: October 18, 2005
• Last Update Posted: June 19, 2015
• Last Verified: June 2015

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

postoperative dental pain; acetaminophen; ibuprofen

Additional relevant MeSH terms:

Toothache; Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Acetaminophen; Ibuprofen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action