Status:
COMPLETED
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Lead Sponsor:
Glenmark Specialty S.A.
Conditions:
Seasonal Allergic Rhinitis (SAR)
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- Male and female subjects aged ≥6 to \<12 years
- Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
- Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
- A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
- Signed informed consent/assent form (subject and parent/caregiver/legal guardian)
Exclusion
- Females of childbearing potential or pregnant
- Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
- History of anaphylaxis and/or other severe local reaction(s) to skin testing
- History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
- Subjects with an active pulmonary disorder or infection.
- Subjects with posterior subcapsular cataracts or glaucoma
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2018
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT03463031
Start Date
March 16 2018
End Date
November 14 2018
Last Update
October 8 2019
Active Locations (32)
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1
Glenmark Investigational Site 18
Mission Viejo, California, United States, 19406
2
Glenmark Investigational Site 32
Ontario, California, United States, 910762
3
Glenmark Investigational Site 30
Paramount, California, United States, 90723
4
Glenmark Investigational Site 17
San Diego, California, United States, 92108