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

Condition(s) targeted: Pain

Intervention: acetaminophen caplets, ibuprofen liquid-filled gelatin capsules (Drug)

Phase: Phase 4

Status: Completed

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

Official(s) and/or principal investigator(s):
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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

Secondary outcome: 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

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) asessment 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.

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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 axiety, 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 absoption 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

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

Ending date: February 2004
Last updated: May 11, 2007