drugset / Trial / NCT01938144

Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America

NCT01938144

Phase 3 Withdrawn Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.

Timeline

Start
2016-04
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 500 mg
Subject Chlorpheniramine Unknown 4 mg Oral
Subject Ibuprofen Small molecule 200 mg Oral
Subject Phenylephrine Small molecule 10 mg Oral

Indications