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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

This study is currently Recruiting

July 2011 By Yuhan Corporation

First Recieved on July 20, 2011

Last Updated on July 21, 2011

Sponsor: Yuhan Corporation
Collaborators:
Information provided by: Yuhan Corporation
Identifier: NCT01400828

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:12 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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

Investigators

Locations

  • Yonsei University college of Medicine, Gangnam Severance Hospital

    Seoul, Korea, Republic of

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