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

• Status: Completed
• Trial end date: 2016-10-05
• Target enrollment: 0
• Participant gender: All

Summary

This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. 17 years to 50 years old

2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive

3. Dental extraction of three or four molars

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

5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

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

2. Known allergy to acetaminophen (ACM) 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