Tolerability and safety of Oxamet® in patients with acute rhinitis

Phase 1

• Conditions: Acute rhinitis.

• Registration Number: EUCTR2004-002276-42-CZ
• Lead Sponsor: IVAX Pharmaceuticals s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-10
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1540

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified