Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT02631551 · View on ClinicalTrials.gov ↗

Study Summary

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Conditions Studied

Interventions

  • DRUG GSP 301 NS
  • DRUG Olopatadine HCl NS
  • DRUG Mometasone furoate NS
  • DRUG GSP 301 Placebo NS

Study Locations (20)

California

  • Investigational Site 20 — Mission Viejo
  • Investigational Site 31 — San Diego
  • Investigational Site 29 — San Jose

Georgia

  • Investigational Site 37 — Marietta
  • Investigational Site 15 — Stockbridge
  • Investigational Site 23 — Stockbridge

Colorado

  • Investigational Site 25 — Centennial
  • Investigational Site 22 — Colorado Springs

Florida

  • Investigational Site 10 — Jupiter
  • Investigational Site 30 — Miami

Maryland

  • Investigational Site 14 — Baltimore
  • Investigational Site 33 — Wheaton

Kentucky

  • Investigational Site 11 — Louisville

Michigan

  • Investigational Site 26 — Ypsilanti

Minnesota

  • Investigational Site 19 — Minneapolis

Trial Details

FieldValue
Enrollment Target 1,180 participants
Start Date 2016-03
Est. Completion 2016-07
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 NCT02631551

The ClinicalTrials.gov registry entry for NCT02631551 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 1,180 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 Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 4 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: NCT02631551 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Georgia, Colorado. 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 NCT02631551 about?

NCT02631551 is a clinical study titled "Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)". Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

What is the current status of trial NCT02631551?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,180 participants. The study started on 2016-03. Estimated completion is 2016-07.

What conditions does trial NCT02631551 study?

This clinical trial studies the following conditions: Seasonal 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 NCT02631551?

The interventions under investigation include: GSP 301 NS (DRUG), Olopatadine HCl NS (DRUG), Mometasone furoate NS (DRUG), GSP 301 Placebo NS (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02631551?

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 NCT02631551 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Kentucky. 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