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COMPLETED Phase 3

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

NCT02709538 · View on ClinicalTrials.gov ↗

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.

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02709538

The ClinicalTrials.gov registry entry for NCT02709538 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 601 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glenmark Specialty S.A., which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02709538 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02709538?

This trial is sponsored by Glenmark Specialty S.A., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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