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

Vasomotor Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509209
• Other study ID #: HM-LCT-301
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2012
• Last updated: May 22, 2013
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

randomized, double-blind, placebo-controlled, phase 3

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of vasomotor rhinitis

Exclusion Criteria:

• Significant concomitant medical condition

• Use corticosteroids or other allergy medications during the study

• Considered by investigator as not appropriate to participate in the clinical study with othe reason

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Vasomotor
• Vasomotor Rhinitis

Intervention

Drug:
• Pseudoephedrine / Levocetirizine
tablet, BID everyday

Locations

Country	Name	City	State
Korea, Republic of	ear, nose and throat, Boramae Hospital	Dongjak	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TVRSS(Total Vasomotor Rhinitis Symptom Score)	the change from baseline in TVRSS	2week	No
Secondary	TVRSS, VRSS	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	1week or 2 week	No