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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2013

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

Interventions

  • Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
    • 5ml each 4 hours
  • Drug: Syrup of guaifenesin
    • 5ml each 4 hours

Arms, Groups and Cohorts

  • Experimental: DRUG 1
    • Syrup of oxomemazine, guaifenesin and potassium iodate
  • Active Comparator: DRUG 2
    • Syrup of guaifenesin

Clinical Trial Outcome Measures

Primary Measures

  • Reduction/improvement of cough symptoms
    • Time Frame: DAY 7
    • The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Secondary Measures

  • Tolerance
    • Time Frame: DAY 7
    • Adverse events will be collected and followed in order to evaluate safety and tolerability

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Felipe Pinho, MD, Study Director, EMS

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