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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR CETIRIZINE HYDROCHLORIDE HIVES

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505(b)(2) Clinical Trials for Cetirizine Hydrochloride Hives

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.
OTC NCT02865018 Neuromyelitis Optica (NMO) & Cetirizine Completed Icahn School of Medicine at Mount Sinai 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 Cetirizine Hydrochloride Hives

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00150761 Facial Thermography Study of Levocetirizine Versus Cetirizine Completed UCB Pharma Phase 4 2004-07-01 Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.
NCT00189397 Azathioprine Versus Corticosteroids in Parthenium Dermatitis Completed All India Institute of Medical Sciences, New Delhi N/A 2003-02-01 The dermatitis caused by the substances which come in contact with the skin is known as contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the commonest cause of ABCD in India though in some cases other plants have also been found to cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our country. Though it has very little mortality, the disease normally continues to persist with variable remissions and relapses causing great distress and morbidity. Corticosteroids, topical and systemic have been the mainstay of the treatment so far. Therefore, the patients with ABCD who have to take corticosteroids for long periods of time tend to develop severe and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able to induce remissions in these patients with azathioprine used as daily as well as monthly bolus dose, without having to use systemic corticosteroids. The side effect with azathioprine in these studies were almost absent. We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse doses versus daily azathioprine in achieving remissions in patients having Parthenium dermatitis and to monitor the side effects of both the regimens.
NCT00253058 Study Of Perennial Allergic Rhinitis In Pediatrics Completed GlaxoSmithKline Phase 3 2005-07-01 To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period
NCT00257569 Study Of Atopic Dermatitis In Pediatrics Completed GlaxoSmithKline Phase 3 2005-08-01 To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
NCT00257582 Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics Completed GlaxoSmithKline Phase 3 2005-08-01 To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.
NCT00257595 Perennial Allergic Rhinitis In Pediatric Subjects Completed GlaxoSmithKline Phase 3 2005-08-01 To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
NCT00291642 Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen Completed UCB Pharma Phase 2 2006-01-01 The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of SAR in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cetirizine Hydrochloride Hives

Condition Name

Condition Name for Cetirizine Hydrochloride Hives
Intervention Trials
Allergic Rhinitis 10
Healthy 8
Seasonal Allergic Rhinitis 8
Rhinitis, Allergic, Seasonal 5
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Condition MeSH

Condition MeSH for Cetirizine Hydrochloride Hives
Intervention Trials
Rhinitis 32
Rhinitis, Allergic 31
Rhinitis, Allergic, Seasonal 14
Urticaria 10
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Clinical Trial Locations for Cetirizine Hydrochloride Hives

Trials by Country

Trials by Country for Cetirizine Hydrochloride Hives
Location Trials
United States 36
Canada 10
Germany 4
Japan 3
Italy 2
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Trials by US State

Trials by US State for Cetirizine Hydrochloride Hives
Location Trials
Texas 5
Maryland 4
North Carolina 3
New York 2
Florida 2
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Clinical Trial Progress for Cetirizine Hydrochloride Hives

Clinical Trial Phase

Clinical Trial Phase for Cetirizine Hydrochloride Hives
Clinical Trial Phase Trials
Phase 4 18
Phase 3 16
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cetirizine Hydrochloride Hives
Clinical Trial Phase Trials
Completed 53
Not yet recruiting 7
Recruiting 5
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Clinical Trial Sponsors for Cetirizine Hydrochloride Hives

Sponsor Name

Sponsor Name for Cetirizine Hydrochloride Hives
Sponsor Trials
GlaxoSmithKline 12
UCB Pharma 6
Merck Sharp & Dohme Corp. 5
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Sponsor Type

Sponsor Type for Cetirizine Hydrochloride Hives
Sponsor Trials
Industry 58
Other 28
NIH 2
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