This is a prospective, randomized, double-blind and controlled trial to determine the sensory perception of two different decongestive nasal sprays using post-surgical treatment following nasal septum or nasal turbinate corrections as a model..

Phase 1

• Conditions: Post-operative nasal blockage following surgical interventions of the nasal cavity.; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2019-004936-52-DE
• Lead Sponsor: Cassella-med GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

- 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

Study & Design

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