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

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: Acetaminophen (ACE) (1000 mg); Drug: Commercial ACE (1000 mg); Drug: Commercial Ibuprofen (IBU) (400 mg); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02320708

CO-140128120904-PACT

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

Test Acetaminophen (ACE) (1000 mg) and placebo

Experimental group

Treatment:

Drug: Placebo

Drug: Acetaminophen (ACE) (1000 mg)

Drug: Placebo

Drug: Placebo

Commerical ACE (1000 mg) and placebo

Active Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Commercial ACE (1000 mg)

Drug: Placebo

Commerical Ibuprofen (IBU) (400 mg) and placebo

Active Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Commercial Ibuprofen (IBU) (400 mg)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo