Post-operative nasal blockage following surgical interventions of the nasal cavity.
Conditions
Interventions
Trade Name: nasic neo
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Xylometazoline hydrochloride
CAS Number: 1218-35-5
Other descriptive name: XYLOMETAZOLINE HYDROCHLORIDE
Concentrat
Sponsors
Cassella-med GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed and dated ICF - Female or male patients between 18 and 64 years - Non-pregnant, non-nursing women with adequate contraception - Patients with post-operative nasal blockage following surgical interventions of the nasal cavity - Surgical intervention must have been performed at least 1 week ago 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who are simultaneously participating in other clinical trials or who have participated in a clinical trial within the previous 30 days prior to inclusion in the present trial - Pregnancy, lactation, women without reliable contraception - Patients in whom acute infections or epistaxis are detected by endoscopic examination of both nasal cavities - Patients with a hypersensitivity (allergy) to the active ingredients xylometazoline hydrochloride or dexpanthenol and to the other components of nasic neo (sodium hyaluronate, potassium dihydrogen phosphate, sodium monohydrogen phosphate dodecahydrate) and nasic duo (potassium dihydrogen phosphate, disodium hydrogen phosphate) - Patients with dry inflammation of the nasal mucosa (rhinitis sicca) - Patients undergoing surgical removal of the pituitary gland through the nose (transphenoidal hypophysectomy) or other surgical procedures that expose the dura mater - Patients treated with monoamine oxidase (MAO) inhibitors and other potentially hypertensive drugs - Patients treated with alpha inhibitors (e.g. Prazosin, Tamsulosin, Urapidil etc) - Patients with increased intraocular pressure, especially glaucoma (narrow angle glaucoma) - Patients with severe cardiovascular diseases (e.g. coronary heart disease, hypertension and long QT syndrome) - Patients with a tumor of the adrenal gland (pheochromocytoma) - Patients with metabolic disorders, such as hyperthyroidism and diabetes mellitus - Patients with the metabolic disease porphyria - Patients with prostate enlargement (prostate hyperplasia) - Addiction to alcohol or drug - Insufficient knowledge of the national language, which endangers the compliance with the regulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to assess the sensory quality of the nasic neo nasal spray compared to a comparative preparation with the same active ingredient composition. It is assumed that the modified galenics due to the addition of hyaluronic acid improves the sensory quality of the nasal spray. ;Secondary Objective: Secondary objectives of the trial are the following: - Assessment of the sensory quality of nasal sprays during the course of Treatment (intra-group comparison) - Assessment of the sensory quality of the nasal sprays in individual sensoric score items of the nasal-spray-sensoric scale at first application (inter-group comparison) - Evaluation of the safety and clinical tolerability of the application of the nasic neo nasal spray in comparison to the nasal spray Nasic Duo Nasal Spray after nasal surgery - Evaluation of further clinical effects of the application of the nasal spray nasic neo (xylometazoline, dexpanthenol and hyaluronic acid) in comparison to the active substance combination xylometazoline and dexpanthenol (nasal spray nasal duo);Primary end point(s): The primary endpoint of the study is the difference in the sum score in the nasal-spray-sensoric scale between nasic neo and the comparator product after first application. ;Timepoint(s) of evaluation of this end point: Independently of each other, the differences in the sum score in the nasal-spray-sensoric scale for both nasal sprays will be analysed by using the evaluations after the respective first application (baseline values at V1 and V3) (inter-group differences). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Assessment of the sensory quality of nasal sprays during the course of treatment (intra-group comparison) - Assessment of the sensory quality of nasal sprays in the individual sensory queries of the nasal spray sensory scale at first application (inter-group comparison) The sensory assessment is further evaluated by: - the comparison of intra-group changes in sensory evaluation from the nasal spray sensory scale during the course of treatment (V1-V2 vs. V3-V4) for the cumulative score as well as the individual sensory scores - the comparison of the inter-group differences of the sensory evaluation in the individual sensory queries of the nasal spray sensory scale after the first application (baseline values at V1 and V3) To assess the safety and clinical tolerability of the use of both nasal sprays, the following endpoints will be analysed: - description of adverse events - Description of the physical examination and measurement of vital parameters - Description of the ENT medical examination;Timepoint(s) of evaluation of this end point: Inter-group differences in the sensory Evaluation will be compared at the respective baseline visits V1 and V3 Intra-group differences in the sensory evaluation will be compared during the course of treatment (V1-V2; V3-V4) Safety and clinical tolerability will be evaluated during the entire course of the study (V1 - V4) | — |
Countries
Germany
Contacts
Public ContactContract Research Organization
ClinCompetence Cologne GmbH
Outcome results
None listed