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Clinical Trial Summary

Title of Study:

A randomized, parallel, double-blind, multi-center, comparative study to evaluate the efficacy and safety of Cosalin monotherapy versus Cosalin and Xarlin combination therapy in patients with allergic rhinitis

Objective of study:

To exploratively evaluate superiority of combination therapy - twice-daily Cosalin Tab (Petasites hybridus CO2 extract) with once-daily Xarlin Tab (Levocetirizine HCl) - compared to monotherapy of Cosalin with allergic rhinitis subjects.


Clinical Trial Description

Number of Subjects:

Total 100 subjects / Each group 50 subjects (combination therapy group, monotherapy group / include 20% of subjects drop out rate)

Test Products:

Cosarlin (Petasites hybridus CO2 extract) 30 mg tablet Xarlin (Levocetirizine HCl) 5 mg tablet

Study Design:

Development Phase: Phase IV Randomized, double blind, active-controlled, multi-center study

The subject, who is to satisfy inclusion criteria and not to satisfy any of exclusion criteria will be allocated 1:1 to combination therapy group or mono therapy group, randomized.

Written informed consent will be obtained from the subjects prior to study entry.

Dose, Mode of administration:

Monotherapy group - Cosalin 30mg tablet two times daily. Combination therapy group - Cosalin 30mg tablet two times daily and Xarlin 5mg tablet once daily.

Duration of Tx:

2 Weeks

Safety Endpoint:

Physical Exam, Adverse Events, Vital Signs at Visit 2 and 3. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01062139
Study type Interventional
Source CJ HealthCare Corporation
Contact
Status Enrolling by invitation
Phase Phase 4
Start date October 2009

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