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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR OXYMETAZOLINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Oxymetazoline Hydrochloride

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 NCT00487032 Differential Adrenoreceptor Mediated Tachyphylaxis and Upregulation Completed Brian J Lipworth Phase 4 2008-05-01 The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.
OTC NCT02062996 Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption Withdrawn Richard Cartabuke Phase 2 2014-06-01 Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Although there is generally limited vascular absorption, when administered in larger doses, uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH anesthesia department recently reported a case of oxymetazoline induced postoperative hypertension in a three-year-old child following inferior turbinate reduction and adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline and insert a varying number of pledgets during surgical procedures or instill oxymetazoline drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding the method of administration and the absorption of oxymetazoline or the dose-response relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric population.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Oxymetazoline Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00487032 Differential Adrenoreceptor Mediated Tachyphylaxis and Upregulation Completed Brian J Lipworth Phase 4 2008-05-01 The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.
NCT00520104 Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine Unknown status Javelin Pharmaceuticals Phase 1 2007-08-01 This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.
NCT00552110 Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500) Completed Quintiles, Inc. Phase 2 2007-07-01 The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Oxymetazoline Hydrochloride

Condition Name

Condition Name for Oxymetazoline Hydrochloride
Intervention Trials
Allergic Rhinitis 6
Rosacea 4
Anesthesia 3
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Condition MeSH

Condition MeSH for Oxymetazoline Hydrochloride
Intervention Trials
Rhinitis 11
Rhinitis, Allergic 8
Rosacea 4
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Clinical Trial Locations for Oxymetazoline Hydrochloride

Trials by Country

Trials by Country for Oxymetazoline Hydrochloride
Location Trials
United States 19
United Kingdom 4
Bulgaria 2
Brazil 1
Germany 1
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Trials by US State

Trials by US State for Oxymetazoline Hydrochloride
Location Trials
Texas 3
Pennsylvania 2
Ohio 2
Colorado 1
New York 1
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Clinical Trial Progress for Oxymetazoline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Oxymetazoline Hydrochloride
Clinical Trial Phase Trials
Phase 4 10
Phase 3 5
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Oxymetazoline Hydrochloride
Clinical Trial Phase Trials
Completed 19
Recruiting 6
Not yet recruiting 4
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Clinical Trial Sponsors for Oxymetazoline Hydrochloride

Sponsor Name

Sponsor Name for Oxymetazoline Hydrochloride
Sponsor Trials
St. Renatus, LLC 5
Rho, Inc. 5
Triligent International 3
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Sponsor Type

Sponsor Type for Oxymetazoline Hydrochloride
Sponsor Trials
Industry 36
Other 19
U.S. Fed 1
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