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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01257243
First received: December 8, 2010
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Cough
Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
Drug: Syrup of guaifenesin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Reduction/improvement of cough symptoms [ Time Frame: DAY 7 ] [ Designated as safety issue: No ]
    The reduction of cough symptoms will be evaluated by comparative score index basal and final score


Secondary Outcome Measures:
  • Tolerance [ Time Frame: DAY 7 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257243

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

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

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01257243     History of Changes
Other Study ID Numbers: OGPGEMS0110
Study First Received: December 8, 2010
Last Updated: February 26, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
cough
symptoms
cold
flu

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

ClinicalTrials.gov processed this record on August 28, 2014