Who is sponsoring GSP 301-303?

GSP 301-303 is sponsored by Glenmark Specialty S.A..

What condition does GSP 301-303 study?

GSP 301-303 studies Perennial Allergic Rhinitis.

What drugs are being tested in GSP 301-303?

Interventions: GSP 301 NS, GSP 301 Placebo NS pH 3.7, GSP 301 Placebo NS pH 7.0.

What is the status of GSP 301-303?

GSP 301-303 is currently COMPLETED.

Last reviewed 2020-02-12 · How we verify

A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR) (GSP 301-303)

NCT02709538 Phase 3 COMPLETED Results posted

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Details

Lead sponsor	Glenmark Specialty S.A.
Phase	Phase 3
Status	COMPLETED
Enrolment	601
Start date	2016-04
Completion	2017-07

Conditions

Perennial Allergic Rhinitis

Interventions

GSP 301 NS
GSP 301 Placebo NS pH 3.7
GSP 301 Placebo NS pH 7.0

Primary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs). — 52 weeks
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.

Countries

United States