drugset / Trial / NCT01365052

Safety Trial of Naproxen Sodium/ Diphenhydramine

NCT01365052

Phase 3 Completed 326 enrolled Bayer
RandomizedParallel-groupTriple-blind

Summary

The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.

Timeline

Start
2011-05
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Diphenhydramine Unknown 50 mg Oral
Subject Naproxen Small molecule 440 mg Oral

Indications

No indication recorded.