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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Collaborator: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Acetaminophen; Ibuprofen

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