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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02709538
Other study ID # GPL/CT/2014/018/III
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2016
Est. completion date July 2017

Study information

Verified date February 2020
Source Glenmark Specialty S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


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Study Design


Intervention

Drug:
GSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
GSP 301 Placebo NS pH 3.7
2 spray in each nostril twice daily for 52 weeks
GSP 301 Placebo NS pH 7.0
2 spray in each nostril twice daily for 52 weeks

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Sponsors (1)

Lead Sponsor Collaborator
Glenmark Specialty S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-emergent Adverse Events (TEAEs). All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported. 52 weeks
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