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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 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

Sponsor: EMS

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerance [ Time Frame: DAY 7 ]

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


Original Secondary Outcome: Same as current

Information By: EMS

Dates:
Date Received: December 8, 2010
Date Started: February 2013
Date Completion: September 2013
Last Updated: February 26, 2013
Last Verified: February 2013