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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Time to first confirmed perceptible pain relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •17 years to 50 years old
- •Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
- •Dental extraction of three or four molars
- •Experience moderate to severe pain after extraction of third molars
- •Females of childbearing age must be willing to use acceptable method of birth control
Exclusion Criteria
- •Currently pregnant or planning to be pregnant or nursing a baby
- •Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
- •Inability to swallow whole large tablets or capsules
- •Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
Arms & Interventions
Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Intervention: Placebo Caplet (Drug)
Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Intervention: Placebo Liquid-filled capsule (Drug)
Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Intervention: acetaminophen Tablet (Drug)
Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Intervention: acetaminophen Caplet (Drug)
Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Intervention: Placebo Tablet (Drug)
Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Intervention: Placebo Liquid-filled capsule (Drug)
Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Intervention: ibuprofen Liquid-filled capsule (Drug)
Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Intervention: Placebo Tablet (Drug)
Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Intervention: Placebo Caplet (Drug)
Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
Intervention: Placebo Tablet (Drug)
Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
Intervention: Placebo Caplet (Drug)
Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
Intervention: Placebo Liquid-filled capsule (Drug)
Outcomes
Primary Outcomes
Time to first confirmed perceptible pain relief
Time Frame: 6 hours
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Secondary Outcomes
- Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)(30 minutes or less)
- Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)(10 minutes or less)
- Percentage of subjects with meaningful relief by 30 minutes(30 minutes or less)
- Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)(15 minutes or less)
- Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)(20 minutes or less)
- Time to meaningful pain relief(6 hours)