EFFICACY AND SAFETY OF INTRANASAL S0597 IN AN ENVIRONMENTAL EXPOSURE UNIT MODEL OF SEASONAL ALLERGIC RHINITIS: A PHASE 2, SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO, AND ACTIVE-CONTROLLED PARALLEL GROUP STUDY

Registry ID

SPARC_LTD._CLR_13_10

Source registry

HEALTH_CANADA

Status

Ongoing

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

SUN PHARMA ADVANCED RESEARCH COMPANY LTD.

Start date

2013-11-15

Last update

2013-10-28

Conditions

• SEASONAL ALLERGIC RHINITIS

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• A SINGLE-CENTRE, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PARALLEL-GROUP, COMPARATIVE ENVIRONMENTAL EXPOSURE CHAMBER (EEC) STUDY TO EVALUATE EFFICACY, SAFETY AND TOLERABILITY OF TWO FIXED DOSE COMBINATION (FDC) PRODUCTS OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE NASAL SPRAY AS COMPARED TO THE FDC OF AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE NASAL SPRAY, OLOPATADINE NASAL SPRAY, AND PLACEBO IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

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