NCT01938144

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

Three-day Clinical Evaluation Of The Efficacy And Safety Of Two Ibuprofen Combination Products For The Symptomatic Treatment Of The Common Cold And Flu: A Multicenter Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Advil Congestion Relief	Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
DRUG	Advil Allergy and Congestion Relief	Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
DRUG	Paracetamol	Acetaminophen 500 mg, 4x/day, up to 8 doses.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-09-10
• Last updated: 2015-10-14