Study of Acetaminophen (ACE) in Post-operative Dental Pain

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• Collaborator: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

1. Are 17 to 50 years of age

2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)

3. Dental extraction of three or four third-molars.

4. Experience moderate to severe pain after extraction of third molars

Exclusion Criteria:

1. Currently pregnant (or planning to be pregnant) or nursing a baby

2. Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs (NSAIDs)

3. Inability to swallow whole large tablets or capsules

4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study