GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
NCT ID: NCT04060316
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
99 participants
INTERVENTIONAL
2023-12-31
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GLS-1200
3 ml of GLS-1200 (1 mg/ml in 0.9% saline)
GLS-1200
GLS-1200 is given as a nasal spray using an atomizer
Sterile Saline
3 ml of 0.9% saline
Placebo
Placebo is given as a nasal spray using an atomizer
Interventions
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GLS-1200
GLS-1200 is given as a nasal spray using an atomizer
Placebo
Placebo is given as a nasal spray using an atomizer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Able and willing to comply with study procedures
* Elective FESS
* Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential
Exclusion Criteria
* History of primary ciliary dyskinesia
* Known allergy to quinine, quinidine or mefloquine
* Know latex allergy
* History of hematologic malignancy
* History of bone marrow transplantation
* Current or planned chemotherapy treatment for hematologic or solid tumor during study period
* FESS performed non-electively and /or in preparation for decontamination of the sinuses related to cystic fibrosis or in preparation for chemotherapy, solid organ transplantation, or bone marrow transplantation
18 Years
ALL
No
Sponsors
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GeneOne Life Science, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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T2R-001
Identifier Type: -
Identifier Source: org_study_id
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