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 ]
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