Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004936-52
    Sponsor's Protocol Code Number:CASK0119
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-004936-52
    A.3Full title of the trial
    Prospective, controlled, randomized double-blind study to determine the sensory perception of two nasal sprays using the model of treatment of post-operative complaints after surgery on the nasal mucosa.
    Prospektive, kontrollierte, randomisierte Doppelblindprüfung zur Erhebung der sensorischen Wahrnehmung zweier Nasensprays am Modell der Behandlung post-operativer Beschwerden nach Eingriffen an der Nasenschleimhaut.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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..
    A.4.1Sponsor's protocol code numberCASK0119
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCassella-med GmbH & Co KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCassella-med GmbH & Co KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinCompetence Cologne GmbH
    B.5.2Functional name of contact pointContract Research Organization
    B.5.3 Address:
    B.5.3.1Street AddressGenter Str. 7
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50672
    B.5.3.4CountryGermany
    B.5.4Telephone number+492217161330
    B.5.5Fax number+4922171613329
    B.5.6E-mailinfo@clincompetence.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name nasic neo
    D.2.1.1.2Name of the Marketing Authorisation holderCassella-med GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXylometazoline hydrochloride
    D.3.9.1CAS number 1218-35-5
    D.3.9.3Other descriptive nameXYLOMETAZOLINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05152MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexpanthenol
    D.3.9.1CAS number 81-13-0
    D.3.9.3Other descriptive nameDEXPANTHENOL
    D.3.9.4EV Substance CodeSUB07042MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NasenDuo Nasenspray
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNasenDuo Nasenspray
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNxylometazoline hydrochloride
    D.3.9.1CAS number 1218-35-5
    D.3.9.3Other descriptive nameXYLOMETAZOLINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05152MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdexpanthenol
    D.3.9.1CAS number 81-13-0
    D.3.9.3Other descriptive nameDEXPANTHENOL
    D.3.9.4EV Substance CodeSUB07042MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative nasal blockage following surgical interventions of the nasal cavity.
    E.1.1.1Medical condition in easily understood language
    Patients suffering from post-operative nasal decongestion after a surgical intervention on the nasal septum or the nasal turbinates have been performed.
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Ziel der Studie ist die Beurteilung der sensorischen Qualität des Nasensprays nasic neo gegenüber einem Vergleichspräparat mit gleicher Wirkstoffzusammensetzung.
    Es wird angenommen, dass die durch Hinzufügung von Hyaluronsäure veränderte Galenik die Sensorik des Nasensprays verbessert.
    E.2.2Secondary objectives of the trial
    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)
    Weitere Ziele der Studie sind:
    - Beurteilung der sensorischen Qualität der Nasensprays im Verlauf der Behandlung (Intra-Gruppen-Vergleich)
    - Beurteilung der sensorischen Qualität der Nasensprays in den einzelnen Sensorik-Abfragen der Nasenspray Sensorik-Skala bei Erstanwendung (Inter-Gruppen-Vergleich)
    - Beurteilung der Sicherheit und klinischen Verträglichkeit der Anwendung des Nasensprays nasic neo im Vergleich zum Nasenspray NasenDuo Nasenspray nach Eingriffen an der Nasenschleimhaut
    - Beurteilung weiterer klinischen Effekte der Anwendung des Nasensprays nasic neo (Xylometazolin, Dexpanthenol und Hyaluronsäure) im Vergleich zur Wirkstoffkombination Xylometazolin und Dexpanthenol (Nasenspray NasenDuo)
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    - Unterschriebene und datierte Einwilligungserklärung des Patienten
    - Weibliche oder männliche Patienten zwischen 18 und 64 Jahren
    - Nicht schwangere, nicht stillende Frauen mit einer adäquaten Schwangerschaftsverhütung.
    - Patienten mit post-operativer Nasenatmungsbehinderung nach Eingriffen am Nasen-Septum oder den Nasenmuscheln
    - Operativer Eingriff muss mindestens 1 Woche zurück liegen
    E.4Principal 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
    - Patienten, die gleichzeitig an anderen klinischen Prüfungen teilnehmen oder innerhalb der vorangegangenen 30 Tage vor Einschluss in die vorliegende Studie an einer klinischen Prüfung teilgenommen haben
    - Schwangerschaft, Stillzeit, Frauen ohne zuverlässige Schwangerschaftsverhütung
    - Patienten, bei denen durch endoskopische Untersuchungen beider Nasenhaupthöhlen akute Infektionen oder Epistaxis festgestellt werden
    - Patienten mit einer Überempfindlichkeit (Allergie) gegen die Wirkstoffe Xylometazolinhydrochlorid oder Dexpanthenol sowie gegen die weiteren Bestandteile von nasic neo (Natriumhyaluronat, Kaliumdihydrogenphosphat, Natriummonohydrogenphosphat-Dodecahydrat) und NasenDuo (Kaliumdihydrogenphosphat, Dinatriumhydrogenphosphat)
    - Patienten mit einer trockenen Entzündung der Nasenschleimhaut (Rhinitis sicca)
    - Patienten mit operativer Entfernung der Hirnanhangsdrüse durch die Nase (transphenoidale Hypophysektomie) oder anderen operativen Eingriffen, die die Dura mater freilegen
    - Patienten, die mit Monoaminoxidase-Hemmern (MAO-Hemmern) und anderen potenziell blutdrucksteigernden Arzneimittel behandelt werden
    - Patienten, die mit Alpha-Blockern (z.B. Prazosin, Tamsulosin, Urapidil etc) behandelt werden
    - Patienten mit erhöhtem Augeninnendruck, insbesondere grünem Star (Engwinkelglaukom)
    - Patienten mit schweren Herz- und Kreislauferkrankungen (z.B. koronarer Herzkrankheit, Hypertonie und Long-QT-Syndrom)
    - Patienten mit einem Tumor der Nebenniere (Phäochromozytom)
    - Patienten mit Stoffwechselstörungen, wie z.B. Überfunktion der Schilddrüse (Hyperthyreose) und Zuckerkrankheit (Diabetes mellitus)
    - Patienten mit der Stoffwechselkrankheit Porphyrie
    - Patienten mit Prostatavergrößerung (Prostatahyperplasie)
    - Abhängigkeit von Alkohol oder Drogen
    - Unzureichende Kenntnisse der Landessprache, welche die Einhaltung der Vorschriften gefährden
    E.5 End points
    E.5.1Primary 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.
    Primärer Endpunkt der Studie ist der Unterschied der Summen-Score der Sensorik-Bewertungen aus der Nasenspray Sensorik-Skala zwischen nasic neo gegenüber dem Vergleichspräparat nach erster Anwendung.
    E.5.1.1Timepoint(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).
    Die Unterschiede zwischen den 2 verschiedenen Nasensprays werden im cross-over Design in den Bewertungen der nach der jeweils ersten Anwendung (Baseline-Werte an V1 und V3) unabhängig voneinander analysiert (Inter-Gruppen-Unterschiede).
    E.5.2Secondary 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
    - Die Beurteilung der sensorischen Qualität der Nasensprays im Verlauf der Behandlung (Intra-Gruppen-Vergleich)
    - Die Beurteilung der sensorischen Qualität der Nasensprays in den einzelnen Sensorik-Abfragen der Nasenspray Sensorik-Skala bei Erstanwendung (Inter-Gruppen-Vergleich)

    Die sensorische Beurteilung wird weiterhin bewertet durch:
    - den Vergleich der Intra-Gruppen-Veränderungen der Sensorik-Bewertung aus der Nasenspray Sensorik-Skala im Verlauf der Behandlung (V1-V2 vs. V3-V4) für den Summen-Score sowie die einzelnen Sensorik-Abfragen
    - den Vergleich der Inter-Gruppen-Unterschiede der Sensorik-Bewertung in den einzelnen Sensorik-Abfragen der Nasenspray Sensorik-Skala nach der jeweils ersten Anwendung (Baseline-Werte an V1 und V3)

    Zur Beurteilung der Sicherheit und klinischen Verträglichkeit der Anwendung beider Nasensprays werden die folgenden Endpunkte analysiert:
    - Beschreibung unerwünschter Ereignisse
    - Beschreibung der körperlichen Untersuchung und die Messung der Vitalparameter
    - Beschreibung der HNO-ärztlichen Untersuchung
    E.5.2.1Timepoint(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)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The scope of the study is to assess the sensory quality of 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.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who continue to suffer from post-operative complaints of the nasal mucosa after the end of the study can be treated by the investigator with a mucosal care therapy according to the guidelines (e.g. isotonic nasal sprays, rinses, possibly decongestant nasal sprays and ointments (only for dry crusts over a short period of time)) for about 3 to 4 weeks after surgery.
    Patienten, die nach Beendigung der Studie weiterhin an post-operativen Beschwerden an der Nasenschleimhaut leiden, können durch den Prüfarzt mit einer leitliniengerechten Therapie zur Schleimhautpflege (z.B. isotonische Nasensprays, Spülungen, evtl. abschwellende Nasensprays und Salben nur bei trockenen Krusten über kurzen Zeitraum) für etwa 3 bis 4 Wochen postoperativ nachbehandelt werden.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-04
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 07 09:34:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA