Status:
COMPLETED
Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Lead Sponsor:
Glenmark Pharmaceuticals Ltd. India
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal all...
Eligibility Criteria
Inclusion
- Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test
Exclusion
- Pregnant or lactating women
- Patients with known hypersensitivity to any of the components of the formulation
- Patients with a history of seasonal asthma during ragweed season.
- Patient requiring chronic use of inhaled or systemic corticosteroids
- Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening
- Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator.
- Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy.
Key Trial Info
Start Date :
January 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2014
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03444506
Start Date
January 27 2014
End Date
February 28 2014
Last Update
June 20 2018
Active Locations (1)
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1
Glenmark Investigational Site 1
Mississauga, Ontario, Canada, L4W 1V7