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NCT03463031 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
A Phase 3 study, sponsored by Glenmark Specialty S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 446
- Enrollment target
NCT03463031: Completed Phase 3 study, sponsored by Glenmark Specialty S.A..
NCT03463031 is a Phase 3 study that has completed, run by Glenmark Specialty S.A.. The registered enrollment target is 446 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03463031, a Phase 3 study, has completed, sponsored by Glenmark Specialty S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 446 participants
- Enrollment target
Study Summary
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
Primary Outcome
The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 =
Interventions
- DRUG GSP 301 NS
- DRUG GSP 301 Placebo NS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2018-11-14 |
| Phase | Phase 3 |
What the finished NCT03463031 record still lists
NCT03463031 is an interventional study that assigns participants to a tested intervention. The registered 446 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which GSP 301 NS is the first listed.
NCT03463031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03463031 about?
NCT03463031 is a clinical study titled "Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)". Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
What is the current status of trial NCT03463031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 446 participants. The study started on 2018-03-16. Estimated completion is 2018-11-14.
What interventions are being tested in trial NCT03463031?
The interventions under investigation include: GSP 301 NS (DRUG), GSP 301 Placebo NS (DRUG).
Who is sponsoring clinical trial NCT03463031?
This trial is sponsored by Glenmark Specialty S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03463031's enrollment target sits among peer trials
446 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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