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Cetirizine Dry Syrup

Phase 3

Dermatitis, Atopic | Small molecule | Dermatology |GSK plc|Trials Updated: May 6, 2013

Cetirizine Dry Syrup development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Nov 2005

Cetirizine Dry Syrup target and mechanism

Molecular targetHRH1
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment654

FDA Designations

No designations recorded

Cetirizine Dry Syrup clinical trials

Cetirizine Dry Syrup · 4 trials · 3 indications

Phase 3 4
NCT00257569Study Of Atopic Dermatitis In PediatricsDermatitis, Atopic
COMPLETED278 Analytics
NCT00257582Study Of Cutaneous Disease Accompanied With Pruritus In PediatricsPruritus
COMPLETED60 Analytics
NCT00257595Perennial Allergic Rhinitis In Pediatric SubjectsRhinitis, Allergic, Perennial
COMPLETED30 Analytics
NCT00253058Study Of Perennial Allergic Rhinitis In PediatricsRhinitis, Allergic, Perennial
COMPLETED286 Analytics
PHASE3COMPLETED
Study Of Atopic Dermatitis In Pediatrics
Dermatitis, AtopicUnlock trial analytics
PHASE3COMPLETED
Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
PruritusUnlock trial analytics
PHASE3COMPLETED
Perennial Allergic Rhinitis In Pediatric Subjects
Rhinitis, Allergic, PerennialUnlock trial analytics
PHASE3COMPLETED
Study Of Perennial Allergic Rhinitis In Pediatrics
Rhinitis, Allergic, PerennialUnlock trial analytics

Study Endpoints

Primary Endpoints

change in the severity of pruritus
To assess the safety
safety
change in the total nasal symptom score (TNSS)

Secondary Endpoints

-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events
-severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Cetirizine Dry SyrupDRUG -
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Eligibility Criteria

Age Range3 Years to 14 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children diagnosed as atopic dermatitis * Giving informed consent * Children who have 2 grades or more pruritus score. * Children who require the treatment with external steroid preparation other than face and head. * Children with a pruritus severity of 2. * Mild or severe on...

Countries:
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Frequently asked questions about Cetirizine Dry Syrup

What is Cetirizine Dry Syrup used for?

Cetirizine Dry Syrup is used for perennial allergic rhinitis, atopic dermatitis, and pruritus (itching) associated with cutaneous disease. It is studied in pediatric subjects, with trial populations including children from 2 or 3 years of age. The conditions studied are allergic and dermatologic in nature.

What does Cetirizine Dry Syrup target?

Cetirizine Dry Syrup targets HRH1, the histamine H1 receptor, acting as an antagonist. By blocking HRH1, it interferes with histamine-mediated allergic and pruritic responses. This mechanism underlies its development for allergic rhinitis, atopic dermatitis, and pruritus.

Who makes Cetirizine Dry Syrup?

GSK plc, which trades under the ticker GSK, is the developer of Cetirizine Dry Syrup. The company is listed as the sponsor of the clinical trials evaluating this formulation in pediatric allergic and dermatologic conditions.

What phase is Cetirizine Dry Syrup in?

Cetirizine Dry Syrup is in Phase 3 development. Both of its recorded trials are Phase 3 studies, and both are completed, with no active trials currently listed. It is an investigational formulation studied in pediatric populations.

What clinical trials is Cetirizine Dry Syrup in?

Cetirizine Dry Syrup has been evaluated in Phase 3 trials including NCT00257595 and NCT00253058 in perennial allergic rhinitis, NCT00257582 in pruritus, and NCT00257569 in atopic dermatitis. All are completed, randomized, double-blind studies in pediatric subjects.

How many patients were enrolled in Cetirizine Dry Syrup trials?

The Cetirizine Dry Syrup clinical program enrolled 316 patients in total across its completed Phase 3 trials. Enrollment included 30 subjects in NCT00257595, 60 in NCT00257582, 278 in NCT00257569, and 286 in NCT00253058.