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Sponsored by: |
Faes Farma, S.A. |
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Information provided by: | Faes Farma, S.A. |
ClinicalTrials.gov Identifier: | NCT00504933 |
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: bilastine Drug: Cetirizine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Randomised, Placebo-Controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Cetirizine 10 mg for the Treatment of Seasonal Allergic Rhinitis. |
Enrollment: | 683 |
Study Start Date: | May 2005 |
Study Completion Date: | November 2005 |
Arms | Assigned Interventions |
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A: Experimental
Bilastine
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Drug: bilastine
20 mg (encapsulated) tablets QD/14days
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B: Active Comparator
Cetirizine
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Drug: Cetirizine
10 mg (encapsulated) tablets. QD/14 days
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C: Placebo Comparator
Placebo
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Drug: Placebo
(encapsulated) Tablets QD/14 days
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In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.
Ages Eligible for Study: | 12 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Faes Farma, S.A. ( Dr. Ander Sologuren ) |
Study ID Numbers: | BILA 1704/RAE, EudraCT number: 2004-004586-14 |
Study First Received: | July 19, 2007 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00504933 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Romania: National Medicines Agency; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health |
Rhinitis Allergic Seasonal Hay Fever |
Pollen Allergy Pollinosis Rhinoconjunctivitis |
Neurotransmitter Agents Otorhinolaryngologic Diseases Rhinitis Anti-Allergic Agents Cetirizine Histamine Fever Hypersensitivity |
Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists Respiratory Hypersensitivity |
Neurotransmitter Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Histamine Agents Rhinitis Anti-Allergic Agents Cetirizine Pharmacologic Actions Nose Diseases |
Hypersensitivity Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Therapeutic Uses Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |