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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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Page 1 of 8 (32 locations)

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