drugset
drugset / Trial / NCT04447040

Acetaminophen/Naproxen Sodium Dose Ranging Study

NCT04447040 ↗

Phase 2 Completed 304 enrolled Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

Timeline

Start
2020-11-09
Primary completion
2021-04-09
Completion
2021-05-03

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Acetaminophen/Naproxen Sodium Dose A; p <0.001; Least square (LS) Mean Difference 31.48 (95% CI 20.90 to 42.07); ANOVA NCT04447040 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule — —
Subject Naproxen Small molecule — —

Indications

No indication recorded.