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

NCT02870205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1176

Last updated 2018-04-06

Study results available
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Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Conditions

  • Seasonal Allergic Rhinitis (SAR)

Interventions

DRUG

GSP 301 NS

2 spray in each nostril twice daily for 14 days

DRUG

GOM-NS

2 spray in each nostril twice daily for 14 days

DRUG

GMM-2 NS

2 spray in each nostril twice daily for 14 days

DRUG

GSP 301 placebo NS

2 spray in each nostril twice daily for 14 days

Sponsors & Collaborators

  • Glenmark Specialty S.A.

    lead INDUSTRY

Principal Investigators

  • Sudeesh Tantry, PhD · Glenmark Pharmaceuticals Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-01-31
Completion
2017-01-31

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 NCT02870205 on ClinicalTrials.gov