Tolerability and safety of Oxamet® in patients with acute rhinitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002276-42-CZ

Enrollment

1540

Registered

2004-11-10

Start date

2004-12-13

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute rhinitis.

Interventions

Trade Name: Oxamet® 0.5‰ Product Name: Oxamet® 0.5‰ Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: oxymetazolini hydrochloridum CAS Number: 2315-02-8 Other descriptive name: oxymetazo

oxymetazolinhydrochlorid Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 0.05-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Male or female at the age of 18-65 years 2.Diagnosis of acute rhinitis 3.Patient assessment of obstruction - level 2 or more Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Nasal abnormalities causing obstruction 2.Significant history of hypersensitivity to oxymetazoline or other components of the tested product 3.Pregnant or lactating females, or likelihood pregnancy 4.Severe cardiovascular disease: hypertension, ischemic heart disease 5.Pacemark-dependent cardiac rhythm 6.Rhinitis sicca 7.Metabolic disorders: diabetes mellitus, hyperthyroidism 8.Pheochromocytoma 9.Men with hyperplasia of prostate 10.No history or evidence of malignancy of nose or paranasal sinuses 11.Concomitant therapy with MAO inhibitors or tricyclic antidepressives 12.Severe respiratory disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of Oxamet® in patients with acute rhinitis. ;Secondary Objective: To demonstrate the efficacy of Oxamet® in patients with acute rhinitis.;Primary end point(s): Assessment of symptoms: - burning - sneezing - itching - dryness of nassal mucosa - stinging Adverse events-character, frequency, severity, causality and intensity level. Vital signs.	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of Oxamet® in patients with acute rhinitis. ;Secondary Objective: To demonstrate the efficacy of Oxamet® in patients with acute rhinitis.;Primary end point(s): Assessment of symptoms: - burning - sneezing - itching - dryness of nassal mucosa - stinging Adverse events-character, frequency, severity, causality and intensity level. Vital signs.

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026