A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)

Trial Profile

A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2017

At a glance

  • Drugs Mometasone/olopatadine (Primary)
  • Indications Perennial allergic rhinitis
  • Focus Adverse reactions; Registrational
  • Sponsors Glenmark Pharmaceuticals S.A.
  • Most Recent Events

    • 13 Dec 2017 According to a company media release, Glenmark plans to submit the company's first new drug application (NDA) to the FDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of 2018. Glenmark will be submitting data from this trial for presentation at upcoming scientific meetings and publication in a peer-reviewed journal.
    • 13 Dec 2017 Top-line results presented in a Glenmark Pharmaceuticals media release.
    • 18 Sep 2017 Status changed from active, no longer recruiting to completed.
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