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

EMS260 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Cough

Interventions

Syrup of oxomemazine, guaifenesin and potassium iodateDRUG

5ml each 4 hours

Syrup of guaifenesinDRUG

5ml each 4 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must be able to understand the study procedures agree to participate and give written consent. 2. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day. 3. Cough score superior to 3. Exclusion Criteria: 1. Pregnancy or risk of pregnancy. 2. Lactation. 3. Fever above 38º C. 4. Patients with bacterial infections of the upper respiratory tract. 5. Any pathology or past medical condition that can interfere with this protocol.

Locations (1)

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

São Paulo, Brazil

Outcomes

Primary Outcomes

Reduction/improvement of cough symptoms

The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Time frame: DAY 7

Secondary Outcomes

Tolerance

Adverse events will be collected and followed in order to evaluate safety and tolerability

Time frame: DAY 7

Data from ClinicalTrials.gov

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