NCT00240864

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_4 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

First QC Date

October 14, 2005

Last Update Submit

June 18, 2015

Conditions

Pain

Keywords

postoperative dental painacetaminophenibuprofen

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Study Arms (3)

001

EXPERIMENTAL

acetaminophen

Drug: acetaminophen

002

EXPERIMENTAL

ibuprofen

Drug: ibuprofen

003

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

placeboDRUG
003
acetaminophenDRUG
001
ibuprofenDRUG
002

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pain

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Completion

February 1, 2004

Last Updated

June 19, 2015

Record last verified: 2015-06