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

McNeil-PPC

Status and phase: Completed; Phase 3

Conditions: Post-operative Dental Pain

Treatments: Drug: Test acetaminophen; Drug: Commercial acetaminophen; Drug: Commercial ibuprofen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03224403

CO-170317095828-PACT

Details and patient eligibility

About

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.

Full description

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Enrollment: 664 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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664 participants in 4 patient groups, including a placebo group

Test acetaminophen

Experimental group

Description:

Test acetaminophen 1000 mg dose

Treatment:

Drug: Test acetaminophen

Commercial acetaminophen

Active Comparator group

Description:

Commercial acetaminophen 1000 mg dose

Treatment:

Drug: Commercial acetaminophen

Commercial ibuprofen

Active Comparator group

Description:

Commercial ibuprofen, 400 mg dose

Treatment:

Drug: Commercial ibuprofen

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo