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A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

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Trial Profile

A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2022

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At a glance

  • Drugs Mometasone/olopatadine (Primary)
  • Indications Seasonal allergic rhinitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Glenmark Pharmaceuticals S.A.

Most Recent Events

  • 23 Sep 2022 According to a Glenmark Pharmaceuticals Ltd media release, RYALTRIS (olopatadine hydrochloride and mometasone furoate nasal spray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.
  • 01 Aug 2022 Results assessing efficacy, safety, and tolerability of GSP301 in pediatric subjects (6-11 years) with seasonal allergic rhinitis, published in the Annals of Allergy, Asthma and Immunology.
  • 08 May 2019 According to a Glenmark Pharmaceuticals Ltd media release, data will be presented at future meetings.

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