Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Public ClinicalTrials.gov record NCT03463031. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Study identification
- NCT ID
- NCT03463031
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Glenmark Specialty S.A.
- Industry
- Enrollment
- 446 participants
Conditions and interventions
Conditions
Interventions
- GSP 301 NS Drug
- GSP 301 Placebo NS Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2018
- Primary completion
- Nov 13, 2018
- Completion
- Nov 13, 2018
- Last update posted
- Oct 7, 2019
2018
United States locations
- U.S. sites
- 32
- U.S. states
- 16
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Glenmark Investigational Site 18 | Mission Viejo | California | 19406 | — |
| Glenmark Investigational Site 32 | Ontario | California | 910762 | — |
| Glenmark Investigational Site 30 | Paramount | California | 90723 | — |
| Glenmark Investigational Site 17 | San Diego | California | 92108 | — |
| Glenmark Investigational Site 21 | Colorado Springs | Colorado | 80907 | — |
| Glenmark Investigational Site 13 | Marietta | Georgia | 30060 | — |
| Glenmark Investigational Site 26 | Savannah | Georgia | 31312 | — |
| Glenmark Investigational Site 28 | Louisville | Kentucky | 40215 | — |
| Glenmark Investigational Site 14 | Baltimore | Maryland | 21236-5992 | — |
| Glenmark Investigational Site 19 | Bethesda | Maryland | 20814-2672 | — |
| Glenmark Investigational Site 25 | Ypsilanti | Michigan | 48197 | — |
| Glenmark Investigational Site 12 | Columbia | Missouri | 65203 | — |
| Glenmark Investigational Site 10 | Rolla | Missouri | 65401 | — |
| Glenmark Investigational Site 27 | Warrensburg | Missouri | 64093 | — |
| Glenmark Investigational Site 15 | Omaha | Nebraska | 68114 | — |
| Glenmark Investigational Site 3 | High Point | North Carolina | 27262-4320 | — |
| Glenmark Investigational Site 8 | Raleigh | North Carolina | 27607 | — |
| Glenmark Investigational Site 11 | Cincinnati | Ohio | 45231 | — |
| Glenmark Investigational Site 29 | Cincinnati | Ohio | 45242 | — |
| Glenmark Investigational Site 2 | Edmond | Oklahoma | 73034 | — |
| Glenmark Investigational Site 33 | Tulsa | Oklahoma | 74136 | — |
| Glenmark Investigational Site 4 | Medford | Oregon | 97504-9741 | — |
| Glenmark Investigational Site 6 | Spartanburg | South Carolina | 29303 | — |
| Glenmark Investigational Site 5 | Austin | Texas | 78759 | — |
| Glenmark Investigational Site 24 | Kerrville | Texas | 78028-6071 | — |
| Glenmark Investigational Site 1 | New Braunfels | Texas | 78130 | — |
| Glenmark Investigational Site 7 | San Antonio | Texas | 78229-3749 | — |
| Glenmark Investigational Site 9 | San Antonio | Texas | 78229 | — |
| Glenmark Investigational Site 20 | Waco | Texas | 76712 | — |
| Glenmark Investigational Site 31 | Waco | Texas | 76712 | — |
| Glenmark Investigational Site 22 | Draper | Utah | 84020 | — |
| Glenmark Investigational Site 23 | Greenfield | Wisconsin | 53288 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03463031, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2019 · Synced Jun 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03463031 live on ClinicalTrials.gov.