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

April 15, 2019 updated by: EMS

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

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 Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 02189-000
        • Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DRUG 1
Syrup of oxomemazine, guaifenesin and potassium iodate
Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
5ml each 4 hours
Active Comparator: DRUG 2
Syrup of guaifenesin
Drug: Syrup of guaifenesin
5ml each 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
DAY 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

September 30, 2013

Study Completion (Actual)

October 25, 2013

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGPGEMS0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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