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Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

NCT02709538 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2020-02-26

Study results available
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Summary

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

GSP 301 NS

FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks

DRUG

GSP 301 Placebo NS pH 3.7

2 spray in each nostril twice daily for 52 weeks

DRUG

GSP 301 Placebo NS pH 7.0

2 spray in each nostril twice daily for 52 weeks

Sponsors & Collaborators

  • Glenmark Specialty S.A.

    lead INDUSTRY

Principal Investigators

  • Sudeesh Tantry · 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
2016-04-30
Primary Completion
2017-07-31
Completion
2017-07-31

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 NCT02709538 on ClinicalTrials.gov