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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

December 8, 2010
February 26, 2013
February 2013
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01257243 on ClinicalTrials.gov Archive Site
Tolerance [ Time Frame: DAY 7 ] [ Designated as safety issue: Yes ]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Same as current
Not Provided
Not Provided
 
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
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 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cough
  • Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
    5ml each 4 hours
  • Drug: Syrup of guaifenesin
    5ml each 4 hours
  • Experimental: DRUG 1
    Syrup of oxomemazine, guaifenesin and potassium iodate
    Intervention: Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
  • Active Comparator: DRUG 2
    Syrup of guaifenesin
    Intervention: Drug: Syrup of guaifenesin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Pesquisa Clínica 551138879851 pesquisa.clinica@ems.com.br
Brazil
 
NCT01257243
OGPGEMS0110
No
EMS
EMS
Not Provided
Study Director: Felipe Pinho, MD EMS
EMS
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP