Clinical Trial: Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Brief Summary: The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Detailed Summary: randomized, double-blind, placebo-controlled, phase 3
Sponsor: Hanmi Pharmaceutical Company Limited

Current Primary Outcome: TVRSS(Total Vasomotor Rhinitis Symptom Score) [ Time Frame: 2week ]

the change from baseline in TVRSS


Original Primary Outcome: Same as current

Current Secondary Outcome: TVRSS, VRSS [ Time Frame: 1week or 2 week ]

  • the change from baseline in TVRSS during 1st week and 2nd week
  • the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week


Original Secondary Outcome: TVRSS, VRSS [ Time Frame: 1week or 2 week ]

  • the chanage from baseline in TVRSS during 1st week and 2nd week
  • the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week


Information By: Hanmi Pharmaceutical Company Limited

Dates:
Date Received: January 10, 2012
Date Started: May 2011
Date Completion:
Last Updated: May 22, 2013
Last Verified: May 2013