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Last Updated: January 25, 2020

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CLINICAL TRIALS PROFILE FOR ZYRTEC ALLERGY

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505(b)(2) Clinical Trials for Zyrtec Allergy

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02024152 Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg Completed Algorithme Pharma Inc Phase 1 2011-03-01 This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.
OTC NCT02024152 Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg Completed JDP Therapeutics, Inc. Phase 1 2011-03-01 This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.
OTC NCT02865018 Neuromyelitis Optica (NMO) & Cetirizine Completed Guthy Jackson Foundation Phase 1/Phase 2 2014-04-01 Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system. Patients have relapses (also known as attacks) which are often quite severe and leave them with significant disability. Without treatment, within 5 years 50% of NMO patients are blind in one or both eyes or require walking assistance (cane, walker or wheelchair). NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system. This ultimately leads to disability, some of which is permanent. Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody. However, recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell. Specifically, researchers have noted the importance of a specific cell type, eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular over-the-counter allergy medicine. Cetirizine is already known to be safe and well-tolerated in the general population. In this study, the researchers plan to add cetirizine on to patients' current NMO treatment. The researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment. The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zyrtec Allergy

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00240032 A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®. Completed Teva Pharmaceutical Industries Phase 4 2004-10-01 This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.
NCT00375713 Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema Completed UCB Pharma Phase 3 2005-10-01 Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms
NCT00420082 A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Completed Faes Farma, S.A. Phase 2 2006-10-01 This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zyrtec Allergy

Condition Name

Condition Name for Zyrtec Allergy
Intervention Trials
Healthy 6
Allergic Rhinitis 6
Seasonal Allergic Rhinitis 5
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Condition MeSH

Condition MeSH for Zyrtec Allergy
Intervention Trials
Rhinitis 13
Rhinitis, Allergic 12
Rhinitis, Allergic, Seasonal 6
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Clinical Trial Locations for Zyrtec Allergy

Trials by Country

Trials by Country for Zyrtec Allergy
Location Trials
United States 10
Canada 3
Austria 1
Korea, Republic of 1
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Trials by US State

Trials by US State for Zyrtec Allergy
Location Trials
Maryland 3
Texas 3
New York 1
California 1
North Carolina 1
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Clinical Trial Progress for Zyrtec Allergy

Clinical Trial Phase

Clinical Trial Phase for Zyrtec Allergy
Clinical Trial Phase Trials
Phase 4 10
Phase 3 5
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Zyrtec Allergy
Clinical Trial Phase Trials
Completed 24
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for Zyrtec Allergy

Sponsor Name

Sponsor Name for Zyrtec Allergy
Sponsor Trials
Merck Sharp & Dohme Corp. 7
Faes Farma, S.A. 3
Ranbaxy Laboratories Limited 2
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Sponsor Type

Sponsor Type for Zyrtec Allergy
Sponsor Trials
Industry 27
Other 7
NIH 2
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