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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.
Number of Subjects:
Total 100 subjects / Each group 50 subjects (combination therapy group, monotherapy group / include 20% of subjects drop out rate)
Cosarlin (Petasites hybridus CO2 extract) 30 mg tablet Xarlin (Levocetirizine HCl) 5 mg tablet
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:
Physical Exam, Adverse Events, Vital Signs at Visit 2 and 3.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Perennial Allergic Rhinitis
Xarlin (Levocetirizine), Cosalin (Petasites hybridus CO2 extract)
Enrolling by invitation
CJ Cheiljedang Corporation
Published on BioPortfolio: 2014-07-23T21:10:51-0400
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