NCT00504933 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bousquet J, Ansótegui I, Canonica GW, Zuberbier T, Baena-Cagnani CE, Bachert C, Cruz AA, González SN, Kuna P, Morais-Almeida M, Mullol J, Ryan DP, Sánchez-Borges M, Valiente R, Church MK
Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review. Curr Med Res Opin. 2012 Jan;28(1):131-9. doi: 10.1185/03007995.2011.648263. Epub 2011 Dec 22. Review.
Church MK
Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. Review. Erratum in: Expert Opin Drug Saf. 2012 Jan;11(1):175.
Jáuregui I, García-Lirio E, Soriano AM, Gamboa PM, Antépara I
An overview of the novel H1-antihistamine bilastine in allergic rhinitis and urticaria. Expert Rev Clin Immunol. 2012 Jan;8(1):33-41. doi: 10.1586/eci.11.87. Review.
Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group
Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment

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.

Details for clinical trial NCT00504933

Clinical trial NCT00504933 - References