Rinitis acuta MedDRA version: 8.1 Level: LLT Classification code 10039083 Term: Rhinitis
Conditions
Interventions
Product Name: Antirin
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: OXYMETAZOLINE HYDROCHLORIDE
CAS Number: 2315028
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
Zentiva a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients will have to meet all of the following criteria: • established diagnosis of acute rhinitis. All following criteria must be met: o the occurrence of two nasal symptoms at least: congestion, rhinorrhea, mucosa burning or itching, sneezing o duration of nasal symptoms = 30 days • no topical decongestives during last 7 days • patients between 2 – 7 years, both genders ……Group I • patients between 8 – 18 years, both genders ……Group II • written informed consent obtained of patient s guardian and patient (if possible) • good collaboration with parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Patients meeting any of the following criteria will be excluded from participation in this study: • Rhinitis which originated before more than 30 days • Rhinitis medicamentosa • Rhinitis sicca • Otitis media • patients with unstable bronchial asthma • patients with unstable endocrine disease • patients with the history of narrow angle glaucoma • patients with history of hypersensitivity to the study drug or its excipients • patients taking the following drugs: o the need of administration of local (nasal) corticosteroid drugs o use of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 7 days prior inclusion o Systemic corticosteroids: changes in dose within 7 days prior inclusion o Antihistamin drugs: changes in dose within 7 days prior inclusion o antihypertensive drugs that may influence nasal congestion within 7 days prior inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin) o MAO inhibitors and other drugs with hypertensive potential within 14 days prior inclusion. • patients with the history of nasal polyps • patients with major nasal septum deviation • pregnancy • any other disease or condition which may interfere with study assessments as judged by the investigator • patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months • clinically significant renal/hepatic impairment or serious heartdisease and uncontrolled hypertension • patients with pheochromocytoma • patients presenting any malignant disease • patients likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of ANTIRIN® spray 0,05mg in children 8-18years old and ANTIRIN® gtt 0,025mg in children 2-7 years old in comparison with placebo in both age groups .;Secondary Objective: To determine the safety of ANTIRIN® in children.;Primary end point(s): Symptoms recorded by patient/guardian: Group I: epistaxis, formation of eschars, more frequent sneezing Group II: epistaxis, formation of eschars, more frequent sneezing, feeling of dryness in nasal mucosa, burning sensation All symptoms are rated using four-point scale with following interpretation: 0 = absent symptoms (no sign/symptom evident) 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) VAS (visual analogue scale, 10 cm) will be used for patient/guardian recording of their opinion on the overall tolerance of the medication after finishing the treatment period. | — |
Countries
Czech Republic
Outcome results
None listed