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

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ClinicalTrials.gov Identifier: NCT01257243
Recruitment Status : Unknown
Verified February 2013 by EMS.
Recruitment status was:  Recruiting
First Posted : December 9, 2010
Last Update Posted : February 27, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cough Drug: Syrup of oxomemazine, guaifenesin and potassium iodate Drug: Syrup of guaifenesin Phase 3

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2013
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : September 2013

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Tolerance [ Time Frame: DAY 7 ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257243

Contact: Pesquisa Clínica 551138879851 pesquisa.clinica@ems.com.br

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro Recruiting
São Paulo, Brazil, 02189-000
Principal Investigator: Flávio Sano         
Sponsors and Collaborators
Study Director: Felipe Pinho, MD EMS

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01257243     History of Changes
Other Study ID Numbers: OGPGEMS0110
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013

Keywords provided by EMS:

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Chlorpheniramine, phenylpropanolamine drug combination
Potassium iodate
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Antifungal Agents
Anti-Infective Agents