drugset
drugset / Trial / NCT03566979

Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

NCT03566979 ↗

Phase 3 Completed 501 enrolled Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Timeline

Start
2018-08-13
Primary completion
2019-03-26
Completion
2019-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Naproxen Small molecule 440 mg —

Indications

No indication recorded.