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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
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
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Intervention: Drug: Bilastine
Intervention: Drug: Desloratadine
Intervention: Drug: Placebo
20 mg (encapsulated) tablets QD/14 days
5 mg (encapsulated) tablets QD/14 days
(encapsulated) Tablets QD/14 days
|Ages Eligible for Study:||12 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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