MedTrace Logo

Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

NCT03463031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2019-10-08

Study results available
· View outcomes & findings →

Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Conditions

  • Seasonal Allergic Rhinitis (SAR)

Interventions

DRUG

GSP 301 NS

1 spray in each nostril twice daily for 14 days

DRUG

GSP 301 Placebo NS

1 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
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2018-11-14
Completion
2018-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03463031 on ClinicalTrials.gov