CLINICAL TRIALS PROFILE FOR OXYMETAZOLINE HYDROCHLORIDE
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505(b)(2) Clinical Trials for Oxymetazoline Hydrochloride
| 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| OTC | NCT02062996 ↗ | Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption | Withdrawn | Richard Cartabuke | Phase 2 | 2014-06-01 | Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in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 | >Sponsor | >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. |
| NCT00552110 ↗ | Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500) | Completed | Merck Sharp & Dohme Corp. | 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. |
| NCT00584662 ↗ | Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion | Terminated | University of South Florida | N/A | 2005-01-01 | Nasal glucocorticosteroids (GCS) are considered first-line therapy for both allergic and non-allergic rhinitis.1-3 Nasal congestion can persist despite maximum treatment with intranasal GCS. No other drugs are superior to intranasal GCS in relieving nasal congestion. For example, antihistamines are not effective in relieving congestion.1 Oral decongestants are somewhat beneficial in relieving nasal congestion but can elevate blood pressure, cause restlessness, and cause urinary retention. Oxymetazoline, however, is a potent decongestant and the addition of it to a nasal GCS should add a considerable decongestant benefit. It may also be beneficial in patients with persistent nighttime congestion despite maximum dosages of nasal GCS. Oxymetazoline is currently recommended for three days use because of the proposed risk of rhinitis medicamentosa,4 which is increased nasal congestion caused by prolonged use of nasal decongestant sprays.5-8 The term RM was coined early in the twentieth century after several case reports described patients developing rebound congestion after using first generation intranasal decongestants such as privine hydrochloride and ephedrine for prolonged periods6,7. The histopathology and mechanism of RM has been based on animal models which may not be pertinent to humans.9-13 Studies using oxymetazoline, a newer intranasal decongestant, in individuals without rhinitis have shown conflicting evidence for the development of RM.14-16 For example, normal individuals without rhinitis using oxymetazoline three times daily for four weeks did not develop RM.17 Also, it is unknown the frequency of administration and dosage of oxymetazoline it takes to induce RM or whether RM is just a return to a patient's baseline nasal congestion as present before beginning oxymetazoline. It is also unknown whether RM is more likely or only occurs with older vasoconstrictors such as privine hydrochloride and ephedrine rather than oxymetazoline. Nasal GCS reduce the amount of rebound congestion in patients with perennial allergic rhinitis who have reportedly developed RM.18 Nasal GCS decrease nasal mucosa edema, recruitment of neutrophils and mononuclear cells, cytokine production, and late-phase nasal mediators.19-21 They may offer a protective benefit from the risk of developing RM. Oxymetazoline may also decrease inferior turbinate hypertrophy thereby permitting better adsorption of the nasal GCS. Hypothesis The addition of oxymetazoline to a nasal GCS for fourteen days will decrease the amount of congestion in subjects with allergic or non-allergic rhinitis with persistent congestion despite maximum recommended dosages of a nasal GCS. It is also hypothesized that nasal GCS protect against the development of RM secondary to oxymetazoline. |
| NCT00584987 ↗ | Intranasal Steroids and Oxymetazoline in Allergic Rhinitis | Completed | GlaxoSmithKline | Phase 4 | 2007-06-01 | We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone. |
| NCT00584987 ↗ | Intranasal Steroids and Oxymetazoline in Allergic Rhinitis | Completed | University of Chicago | Phase 4 | 2007-06-01 | We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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