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NCT02709538 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Perennial Allergic Rhinitis, sponsored by Glenmark Specialty S.A..

Completed
Registry status
Phase 3
Development phase
601
Enrollment target
20
Study locations

NCT02709538 is a Phase 3 study of Perennial Allergic Rhinitis that has completed, run by Glenmark Specialty S.A.. The registered enrollment target is 601 participants, above the 461-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT02709538, a Phase 3 study of Perennial Allergic Rhinitis, has completed, sponsored by Glenmark Specialty S.A..

COMPLETED
Registry status
Phase 3
Development phase
601 participants
Enrollment target
20
Study locations

Study 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)

Interventions

  • DRUG GSP 301 NS
  • DRUG GSP 301 Placebo NS pH 3.7
  • DRUG GSP 301 Placebo NS pH 7.0

Study Locations (20)

California

  • Investigational Site 28 - Encinitas
  • Investigational Site 27 - San Diego
  • Investigational Site 29 - San Diego

Florida

  • Investigational Site 26 - Aventura
  • Investigational Site 9 - Miami
  • Investigational Site 33 - Tallahassee

North Carolina

  • Investigational Site 7 - High Point
  • Investigational Site 21 - Raleigh

Arkansas

  • Investigational Site 2 - Hot Springs

Colorado

  • Investigational Site 32 - Denver

Georgia

  • Investigational Site 11 - Stockbridge

Kentucky

  • Investigational Site 4 - Louisville

Maryland

  • Investigational Site 5 - Bethesda

Trial Details

FieldValue
Enrollment Target 601 participants
Start Date 2016-04
Est. Completion 2017-07
Phase Phase 3

Sponsor

Glenmark Specialty S.A.

6 total trials

What the Registry Record Tells You About NCT02709538

The ClinicalTrials.gov registry entry for NCT02709538 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 601 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 461-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (30% higher). The listed sponsor is Glenmark Specialty S.A., which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Perennial Allergic Rhinitis appearing as the primary indexed condition, and to 3 interventions - of which GSP 301 NS is the first listed.

NCT02709538 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, North Carolina.

Frequently Asked Questions

What is clinical trial NCT02709538 about?

NCT02709538 is a clinical study titled "Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)". 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)

What is the current status of trial NCT02709538?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2016-04. Estimated completion is 2017-07.

What conditions does trial NCT02709538 study?

This clinical trial studies the following conditions: Perennial Allergic Rhinitis.

What interventions are being tested in trial NCT02709538?

The interventions under investigation include: GSP 301 NS (DRUG), GSP 301 Placebo NS pH 3.7 (DRUG), GSP 301 Placebo NS pH 7.0 (DRUG).

Who is sponsoring clinical trial NCT02709538?

This trial is sponsored by Glenmark Specialty S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02709538 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Perennial Allergic Rhinitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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