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To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

NCT02318303 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1111

Last updated 2020-10-20

Study results available
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Summary

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

GSP 301-1 NS (QD)

GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril

DRUG

GSP 301-2 NS (BID)

GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril

DRUG

GSP 301 Placebo NS

GSP 301 placebo NS administered as 2 sprays/nostril

DRUG

Olopatadine HCl-1 NS (QD)

Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril

DRUG

Olopatadine HCl-2 NS (BID)

Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril

DRUG

Mometasone Furoate-1 NS (QD)

Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril

DRUG

Mometasone Furoate-2 NS (BID)

Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

Sponsors & Collaborators

  • Glenmark Pharmaceuticals Ltd. India

    lead INDUSTRY

Principal Investigators

  • Sudeesh Tantry, Ph.D · Glenmark Pharmaceuticals Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318303 on ClinicalTrials.gov