drugset / Trial / NCT03224403
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Phase 3
Completed
664 enrolled
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Johnson & Johnson Consumer and Personal Products Worldwide · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-07-19
- Primary completion
- 2018-04-04
- Completion
- 2018-04-12
Outcome
Met primary endpoint
paper FA-acetaminophen 1000 mg had faster median time to onset of pain relief (15.7 min) compared to ES-acetaminophen 1000 mg (20.2 min, p = 0.035) PMID 38505928 ↗
registry analysis (superiority test); Placebo vs Test ACM 1000 mg; p <0.001 NCT03224403 ↗
Publications
- Myers A, Bertoch T, Zhang P, Cooper SA. Clinical validation of a fast-acting acetaminophen: a randomized, active and placebo controlled dental pain study. Curr Med Res Opin. 2024 May;40(5):839-848. doi: 10.1080/03007995.2024.2331159. Epub 2024 Mar 23.
- Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1000 mg | Oral |
| Comparator | Ibuprofen | Small molecule | 400 mg | — |
Indications
No indication recorded.