A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Trial Profile

A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2018

At a glance

  • Drugs Mometasone/olopatadine (Primary) ; Mometasone; Olopatadine
  • Indications Seasonal allergic rhinitis
  • Focus Registrational; Therapeutic Use
  • Acronyms GSP301-301
  • Sponsors Glenmark Pharmaceuticals S.A.
  • Most Recent Events

    • 06 Mar 2018 Results presented in a Glenmark Pharmaceuticals Media Release.
    • 06 Mar 2018 According to a Glenmark Pharmaceuticals media release, data were presented at the AAAAI/WAO Joint Congress.
    • 05 Mar 2018 Primary endpoint (Mean change from baseline in AM and PM reflective total nasal symptom scores (rTNSS) GSP301 Versus Olopatadine) has been met, according to results presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
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