Value through Innovation27 July 2016

Clinical Study Results

  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.254
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Double-blind, randomised, parallel trial to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, twice a day, versus Epinastine 10 mg alone, twice a day, in the treatment of outpatients with perennial allergic rhinitis

    Study Document Trial synopsis 262.254 english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.258
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Phase III Double-blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Perennial Allergic Rhinitis

    Study Document Trial synopsis 262.258 english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.290
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Tablet

    Study Document Trial synopsis 262.290 english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.293
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Dry Syrup - Drug Use - Results Survey of Alesion® Dry Syrup-

    Study Document Trial synopsis 262.293 english
  • BI 671800 - Rhinitis, Allergic, Perennial
    Clinical Study Number 1268.41
    Study Indication Rhinitis, Allergic, Perennial
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, double-blind, triple-dummy, partial crossover (each active treatment with placebo) study using an Environmental Challenge Chamber(ECC) to assess the safety and efficacy of 2 weeks of oral BI 671800 ED 50, 200or 400 mg b.i.d., compared to montelukast 10 mg q.d., fluticasone propionatenasal spray 200 µg q.d. (2 nasal actuations to each nostril of 50 µg) versus placebo in seasonal allergic rhinitis patients out-of-season, sensitive to Dactylisglomerata

    Study Document Trial synopsis 1268.41 english

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