Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

• Status: Completed
• Trial end date: 2018-04-12
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

• 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 to 50 years old

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

3. Dental extraction of three or four third molars

4. Meets post-surgical pain criteria

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, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids

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

5. Use of pain medications 5 or more times per week

6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years

7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

8. Have a positive urine drug screen