NCT01257243

Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

Detailed description

STUDY DESIGN * Open-label, superiority, prospective, parallel group, intent to treat trial * Experiment duration: 7 days * 3 visits (days 1, 2 and 7) * Reduction cough symptoms * Adverse events evaluation

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Syrup of oxomemazine, guaifenesin and potassium iodate	5ml each 4 hours
DRUG	Syrup of guaifenesin	5ml each 4 hours

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-09-30
• Completion: 2013-10-25
• First posted: 2010-12-09
• Last updated: 2019-04-17

Locations

1 site across 1 country: Brazil