E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039083 |
E.1.2 | Term | Rhinitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 . |
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E.2.2 | Secondary objectives of the trial |
To determine the safety of ANTIRIN® in children. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |