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

McNeil-PPC

Status and phase: Completed; Phase 3

Conditions: Post Operative Dental Pain

Treatments: Drug: acetaminophen Tablet; Drug: Placebo Tablet; Drug: acetaminophen Caplet; Drug: ibuprofen Liquid-filled capsule; Drug: Placebo Liquid-filled capsule; Drug: Placebo Caplet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02735122

CO-151027203834-PACT

Details and patient eligibility

About

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.

Full description

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

Enrollment: 420 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

420 participants in 4 patient groups, including a placebo group

Test acetaminophen

Experimental group

Description:

acetaminophen tablet and placebo caplet and placebo liquid-filled capsule

Treatment:

Drug: Placebo Caplet

Drug: acetaminophen Tablet

Drug: Placebo Liquid-filled capsule

Commercial acetaminophen

Active Comparator group

Description:

acetaminophen caplet and placebo tablet and placebo liquid-filled capsule

Treatment:

Drug: Placebo Tablet

Drug: acetaminophen Caplet

Drug: Placebo Liquid-filled capsule

Commercial ibuprofen

Active Comparator group

Description:

ibuprofen liquid-filled capsule and placebo tablet and placebo caplet

Treatment:

Drug: Placebo Caplet

Drug: Placebo Tablet

Drug: ibuprofen Liquid-filled capsule

Placebo

Placebo Comparator group

Description:

Placebo tablet and placebo caplet and placebo liquid-filled capsule

Treatment:

Drug: Placebo Caplet

Drug: Placebo Tablet

Drug: Placebo Liquid-filled capsule