EUCTR2015-005155-27-SI
Active, not recruiting
Phase 1
Comparison of the efficacy and safety of the fixed-dose combination of xylometazoline and dexpanthenol in SeptaNazal® and xylometazoline in nasal congestion in patients after surgery in the nose and paranasal cavity and in patients with acute rhinitis – SeptaNazal DOUBLE clinical study.
Conditionsasal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitisMedDRA version: 19.0Level: HLTClassification code 10028736Term: Nasal congestion and inflammationsSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- asal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitis
- Sponsor
- Krka, d.d., Novo mesto
- Enrollment
- 194
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients after nasal surgery or nasal cavities surgery (Group 1\):
- •Aged 18\-60 years
- •Recent nasal surgery or nasal cavities surgery (patients with chronic rinosinusitis with nasal polyps (CRSwNP) and patients with chronic rinosinusitis without nasal polyps (CRSsNP)
- •Can carry out intranasal administration of the investigational medicinal product
- •Signed Informed consent form
- •Patients with acute rhinitis (Group 2\):
- •Aged 18\-60 years
- •Diagnosed with acute rhinitis
- •Can carry out intranasal administration of the investigational medicinal product
- •Signed Informed consent form
Exclusion Criteria
- •Hypersensitivity to the active substances or to any of the excipients
- •Dry nasal inflammation (rhinitis sicca)
- •History of transsfenoidal hypophysectomy or other surgical procedures in which the dura mater was exposed
- •Patients who are treated with drugs for local or systemic treatment of influenza, and sympathomimetic agents, which contain a medicament for the treatment for cough and/or cold
- •Pregnancy or breast\-feeding
- •Patients with asthma who require treatment with corticosteroids
- •Rhinitis medicamentosa
- •Chronic rhinitis
- •Patients treated with monoamine oxidase inhibitors (MAOIs) or other drugs that may raise blood pressure
- •Patients with increased intraocular pressure, in particular with angle\-closure glaucoma
Outcomes
Primary Outcomes
Not specified
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