Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis (SAR)

In brief

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).

Key facts

Study ID

NCT03463031

Run by

Glenmark Specialty S.A.

People needed

446

Starts

2018-03-16

Expected to finish

2018-11-14

Last updated by the study team

2019-10-08

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Glenmark Investigational Site 18 — Mission Viejo, California, United States
• Glenmark Investigational Site 32 — Ontario, California, United States
• Glenmark Investigational Site 30 — Paramount, California, United States
• Glenmark Investigational Site 17 — San Diego, California, United States
• Glenmark Investigational Site 21 — Colorado Springs, Colorado, United States
• Glenmark Investigational Site 13 — Marietta, Georgia, United States
• Glenmark Investigational Site 26 — Savannah, Georgia, United States
• Glenmark Investigational Site 28 — Louisville, Kentucky, United States
• Glenmark Investigational Site 14 — Baltimore, Maryland, United States
• Glenmark Investigational Site 19 — Bethesda, Maryland, United States
• Glenmark Investigational Site 25 — Ypsilanti, Michigan, United States
• Glenmark Investigational Site 12 — Columbia, Missouri, United States
• Glenmark Investigational Site 10 — Rolla, Missouri, United States
• Glenmark Investigational Site 27 — Warrensburg, Missouri, United States
• Glenmark Investigational Site 15 — Omaha, Nebraska, United States
• Glenmark Investigational Site 3 — High Point, North Carolina, United States
• Glenmark Investigational Site 8 — Raleigh, North Carolina, United States
• Glenmark Investigational Site 11 — Cincinnati, Ohio, United States
• Glenmark Investigational Site 29 — Cincinnati, Ohio, United States
• Glenmark Investigational Site 2 — Edmond, Oklahoma, United States
• Glenmark Investigational Site 33 — Tulsa, Oklahoma, United States
• Glenmark Investigational Site 4 — Medford, Oregon, United States
• Glenmark Investigational Site 6 — Spartanburg, South Carolina, United States
• Glenmark Investigational Site 5 — Austin, Texas, United States
• Glenmark Investigational Site 24 — Kerrville, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.