Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

PHASE3CompletedINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

July 31, 2017

Study Completion Date

July 31, 2017

Conditions
Perennial Allergic Rhinitis
Interventions
DRUG

GSP 301 NS

FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks

DRUG

GSP 301 Placebo NS pH 3.7

2 spray in each nostril twice daily for 52 weeks

DRUG

GSP 301 Placebo NS pH 7.0

2 spray in each nostril twice daily for 52 weeks

Trial Locations (34)

Unknown

Investigational Site 2, Hot Springs

Investigational Site 28, Encinitas

Investigational Site 27, San Diego

Investigational Site 29, San Diego

Investigational Site 32, Denver

Investigational Site 26, Aventura

Investigational Site 9, Miami

Investigational Site 33, Tallahassee

Investigational Site 11, Stockbridge

Investigational Site 4, Louisville

Investigational Site 5, Bethesda

Investigational Site 15, St Louis

Investigational Site 30, Bellevue

Investigational Site 19, Skillman

Investigational Site 18, Corning

Investigational Site 7, High Point

Investigational Site 21, Raleigh

Investigational Site 16, Sylvania

Investigational Site 22, Pittsburgh

Investigational Site 13, Spartanburg

Investigational Site 23, Austin

Investigational Site 24, Austin

Investigational Site 3, Austin

Investigational Site 31, Dallas

Investigational Site 34, El Paso

Investigational Site 6, Kerrville

Investigational Site 14, New Braunfels

Investigational Site 10, San Antonio

Investigational Site 12, San Antonio

Investigational Site 17, San Antonio

Investigational Site 1, San Antonio

Investigational Site 20, San Antonio

Investigational Site 25, Waco

Investigational Site 8, Waco

All Listed Sponsors
lead

Glenmark Specialty S.A.

INDUSTRY

NCT02709538 - Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) | Biotech Hunter | Biotech Hunter