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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)

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: 09 Oct 2019

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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

    • 08 May 2019 According to a Glenmark Pharmaceuticals Ltd media release, data will be presented at future meetings.
    • 08 May 2019 Results presented in a Glenmark Pharmaceuticals Ltd Media Release.
    • 08 May 2019 Primary endpoint ((Change from baseline in average AM and PM subject-reported 12-hour reflective Total Nasal Symptom Score (rTNSS)) has been met.
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