Status:
COMPLETED
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
Lead Sponsor:
EMS
Conditions:
Cough
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 evalu...
Eligibility Criteria
Inclusion
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
- Cough score superior to 3.
Exclusion
- Pregnancy or risk of pregnancy.
- Lactation.
- Fever above 38º C.
- Patients with bacterial infections of the upper respiratory tract.
- Any pathology or past medical condition that can interfere with this protocol.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2013
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01257243
Start Date
October 1 2012
End Date
October 25 2013
Last Update
April 17 2019
Active Locations (1)
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1
Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro
São Paulo, Brazil, 02189-000