Clinical trial NCT02735122: Study of Acetaminophen (ACM) in Post-operative Dental Pain
Official title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Dental Pain
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Consumer and Personal Products Worldwide
First posted: 2016-04-12
Enrollment: 420
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Time to first confirmed perceptible pain relief
timeFrame: 6 hours
Secondary outcomes:
measure: Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)
timeFrame: 30 minutes or less
measure: Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)
timeFrame: 10 minutes or less
measure: Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)
timeFrame: 15 minutes or less
measure: Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)
timeFrame: 20 minutes or less
measure: Percentage of subjects with meaningful relief by 30 minutes
timeFrame: 30 minutes or less
measure: Time to meaningful pain relief
timeFrame: 6 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Derek D. Muse, M.D.
role: PRINCIPAL_INVESTIGATOR
References: