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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)

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2019

At a glance

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

    • 17 Jan 2019 Status changed from recruiting to completed.
    • 21 Aug 2018 Planned End Date changed from 31 Jul 2018 to 30 Sep 2018.
    • 21 Aug 2018 Planned primary completion date changed from 31 Jul 2018 to 30 Sep 2018.
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