drugset / Trial / NCT01448057

Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

NCT01448057

Phase 3 Completed 341 enrolled Novartis
RandomizedParallel-groupSingle-blindTreatment

Summary

The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).

Timeline

Start
2013-07
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 500 mg
Subject Dimethindene Unknown 1 mg
Subject Phenylephrine Small molecule 10 mg