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

NCT02631551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1180

Last updated 2018-09-25

Study results available
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Summary

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

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

Sponsors & Collaborators

  • Glenmark Specialty S.A.

    lead INDUSTRY

Principal Investigators

  • Sudeesh Tantry, PhD · Glenmark Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02631551 on ClinicalTrials.gov