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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 is a Phase 3 study that has completed, run by Glenmark Specialty S.A.. The registered enrollment target is 446 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03463031
The ClinicalTrials.gov registry entry for NCT03463031 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 446 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 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSP 301 NS is the first listed.
NCT03463031 reports 0 study locations.
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.
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