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OpenTrials
Completed

NCT Number: NCT01257243

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

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.

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Key information

Conditions

Cough Common Cold Infections Influenza, Human Orthomyxoviridae Infections Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

São Paulo, 02189-000, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Syrup of oxomemazine, guaifenesin and potassium iodate

Drug

5ml each 4 hours

Syrup of guaifenesin

Drug

5ml each 4 hours

Primary outcomes

  1. 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 outcomes

  1. Tolerance

    Time frame: DAY 7

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

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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