drugset / Trial / NCT02246166

The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.

NCT02246166

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Timeline

Start
2015-01
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 500 mg Oral
Subject Chlorpheniramine Unknown 2 mg Oral
Subject Dextromethorphan Unknown 15 mg Oral
Subject Pseudoephedrine Small molecule 30 mg Oral

Indications