Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,180

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Seasonal Allergic Rhinitis
Interventions
DRUG

GSP 301 NS

FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days

DRUG

Olopatadine HCl NS

2 sprays in each nostril twice daily for 14 days

DRUG

Mometasone furoate NS

2 sprays in each nostril twice daily for 14 days

DRUG

GSP 301 Placebo NS

2 sprays in each nostril twice daily for 14 days

Trial Locations (37)

Unknown

Investigational Site 20, Mission Viejo

Investigational Site 31, San Diego

Investigational Site 29, San Jose

Investigational Site 25, Centennial

Investigational Site 22, Colorado Springs

Investigational Site 10, Jupiter

Investigational Site 30, Miami

Investigational Site 37, Marietta

Investigational Site 15, Stockbridge

Investigational Site 23, Stockbridge

Investigational Site 11, Louisville

Investigational Site 14, Baltimore

Investigational Site 33, Wheaton

Investigational Site 26, Ypsilanti

Investigational Site 19, Minneapolis

Investigational Site 21, St Louis

Investigational Site 16, Bellevue

Investigational Site 12, Skillman

Investigational Site 36, Rochester

Investigational Site 18, Raleigh

Investigational Site 27, Cincinnati

Investigational Site 34, Middleburg Heights

Investigational Site 32, Medford

Investigational Site 35, Portland

Investigational Site 13, Orangeburg

Investigational Site 17, Spartanburg

Investigational Site 3, Austin

Investigational Site 5, Austin

Investigational Site 8, Austin

Investigational Site 1, Kerrville

Investigational Site 7, New Braunfels

Investigational Site 2, San Antonio

Investigational Site 4, San Antonio

Investigational Site 6, San Antonio

Investigational Site 9, San Antonio

Investigational Site 28, Waco

Investigational Site 24, Draper

All Listed Sponsors
lead

Glenmark Specialty S.A.

INDUSTRY

NCT02631551 - Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) | Biotech Hunter | Biotech Hunter