Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis

This study is currently recruiting participants.

Verified January 2012 by Yuhan Corporation

Sponsor:

Information provided by (Responsible Party):

Yuhan Corporation

ClinicalTrials.gov Identifier:

NCT01400828

First received: July 20, 2011

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2011
Last Updated Date	January 25, 2012
Start Date ^ICMJE	June 2011
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 21, 2011)	AUC of TSS [ Time Frame: 14 days ] [ Designated as safety issue: No ] The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01400828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 21, 2011)	Change in TSS. Reflective symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ] Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours. Change in TSS. Instantaneous score [ Time Frame: 14days ] [ Designated as safety issue: No ] Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score). Change in total nasal symptom score (TNSS) [ Time Frame: 14 days ] [ Designated as safety issue: No ] Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment •Change in total non-nasal symptom score (TNNSS) [ Time Frame: 14 days ] [ Designated as safety issue: No ] Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment VAS of discomfort [ Time Frame: 14 days ] [ Designated as safety issue: Yes ] Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0. CGI [ Time Frame: 14 days ] [ Designated as safety issue: No ] Investigator's overall clinical impression (CGI) •Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ) [ Time Frame: 14 days ] [ Designated as safety issue: No ] Quality of Life change versus baseline. responde's rate [ Time Frame: 14 days ] [ Designated as safety issue: No ] Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%). safety assessment [ Time Frame: 14 days ] [ Designated as safety issue: Yes ] comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
Official Title ^ICMJE	Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis
Brief Summary	The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Seasonal Allergic Rhinitis
Intervention ^ICMJE	Drug: Bilastine 20 mg (encapsulated) tablets QD/14 days Drug: Desloratadine 5 mg (encapsulated) tablets QD/14 days Other Name: Aerius Drug: Placebo (encapsulated) Tablets QD/14 days
Study Arm (s)	Experimental: Bilastine Intervention: Drug: Bilastine Intervention: Drug: Bilastine Active Comparator: Desloratadine Intervention: Drug: Desloratadine Intervention: Drug: Desloratadine Placebo Comparator: Placebo Intervention: Drug: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	240
Completion Date	Not Provided
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering. Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination.. Exclusion Criteria: Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed. Patients were not allowed to take forbidden medications or not comply the study requirements. Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded. Pregnant or breast-feeding women were also excluded. Women of childbearing potential had a pregnancy test done
Gender	Both
Ages	12 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01400828
Other Study ID Numbers ^ICMJE	YCD159
Has Data Monitoring Committee	No
Responsible Party	Yuhan Corporation
Study Sponsor ^ICMJE	Yuhan Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yuhan Corporation
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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