Phase 3
N=664
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Post-operative Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT03224403 ↗Enrolled (actual)
664
Serious AEs
0.3%
Results posted
Apr 2021
Primary outcome: Primary: Time to Confirmed Perceptible Pain Relief — NA; 15.7; 20.2; 23.2 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Test acetaminophen (Drug); Commercial acetaminophen (Drug); Commercial ibuprofen (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Confirmed Perceptible Pain Relief |
NA; 15.7; 20.2; 23.2 | <0.001 sig |
| SECONDARY Time to Meaningful Pain Relief |
NA; 46.1; 44.2; 43.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes |
18.6; 75.1 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes |
18.6; 73.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes |
18.6; 70.7 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes |
18.6; 70.7 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes |
18.6; 69.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes |
18.6; 69.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes |
18.6; 67.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes |
18.6; 66.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes |
16.9; 62.7 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes |
15.3; 60.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes |
13.6; 58.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes |
13.6; 56.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes |
13.6; 55.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes |
13.6; 53.8 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes |
10.2; 52.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes |
10.2; 41.4 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes |
8.5; 31.7 | <0.001 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes |
8.5; 25.7 | 0.007 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes |
8.5; 21.7 | 0.026 sig |
| SECONDARY Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes |
8.5; 18.1 | 0.080 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 17 to 50 years old
- Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
- Dental extraction of three or four third molars
- Meets post-surgical pain criteria
- 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, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
- 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
- Use of pain medications 5 or more times per week
- Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years
- History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
- Have a positive urine drug screen
Data sourced from ClinicalTrials.gov (NCT03224403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.