Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-02-03 @ 6:39 AM
Study NCT ID:
NCT02160912
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003440', 'term': 'Croup'}], 'ancestors': [{'id': 'D007827', 'term': 'Laryngitis'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pharyngitis symptom score evaluated by the physician', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)', 'description': 'Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong):\n\n* swollen palatine tonsils\n* swollen lymph nodes in the throat\n* fever\n* cough'}], 'secondaryOutcomes': [{'measure': "Change in patient's general condition evaluated by the physician", 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)', 'description': "Physician's assessment of the general conditions on a 4 point scale (good condition, slightly reduced condition, bad condition, very bad condition)"}, {'measure': 'Change in Evaluation of the hoarseness', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)', 'description': "physician's assessment of the hoarseness of the patient on a 4 point scale (none, mild, moderate, strong)"}, {'measure': 'Change in Dysphagia', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)', 'description': "physician's assessment of dysphagia of the patient on a 4 point scale (none, mild, moderate, strong)"}, {'measure': 'Change in efficacy evaluation by the physician', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week)', 'description': 'Assessment of the efficacy on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good)'}, {'measure': 'Change in efficacy evaluation by the patient', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)', 'description': 'Assessment of the efficacy on a 4 point scale (0\\_bad, 1=sufficient, 2=good, 3=very good)'}, {'measure': 'Change in Evaluation of the tolerability by the physician', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))', 'description': 'Assessment of the tolerability by the physician on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good)'}, {'measure': 'Change in Evaluation of the tolerability by the patient', 'timeFrame': 'Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))', 'description': 'Assessment of the tolerability by the patient on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good)'}, {'measure': 'Change in number and type of adverse events', 'timeFrame': 'Visit 2 (after 3 days) Visit 3 (after 7 days)', 'description': 'incidence of adverse events and correlation with the therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Pharyngitis', 'Acute Laryngitis']}, 'descriptionModule': {'briefSummary': 'In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.\n\nPatients are treated with Ectoin Mund- \\& Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care unit In this non interventional study the therapy process of a total of 90 patients with acute pharyngitis and/or laryngitis for which the physician has planned a therapy with Ectoin Mund- \\& Rachenspray 1% (60 Patients) or Emser Pastillen (30 patients) shall be observed in 8 clinical centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- \\& Rachenspray 1% or Emser Pastillen\n\nExclusion Criteria:\n\n* contraindications according to instructions for use'}, 'identificationModule': {'nctId': 'NCT02160912', 'briefTitle': 'Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bitop AG'}, 'officialTitle': 'Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis', 'orgStudyIdInfo': {'id': 'EctMRS/aLR/2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ectoin Mund- & Rachenspray', 'description': 'treatment with Ectoin Mund- \\& Rachenspray 1%'}, {'label': 'Emser Pastillen', 'description': 'treatment with Emser Pastillen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Norbert Pasch-Facharzt für HNO Heilkunde', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '52078', 'city': 'Aachen', 'country': 'Germany', 'facility': 'HNO Praxis Aachen Brand', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '50667', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Taufik Shahab -Facharzt für HNO Heilkunde', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50933', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Bey - Facharzt f. HNO Heilkunde', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50935', 'city': 'Cologne', 'country': 'Germany', 'facility': 'HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '47051', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'HNo Praxis Dr. Uta Thieme', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '52428', 'city': 'Jülich', 'country': 'Germany', 'facility': 'Dr. Lenzenhuber-Fachärztin für HNO Heilkunde', 'geoPoint': {'lat': 50.92149, 'lon': 6.36267}}, {'zip': '52428', 'city': 'Jülich', 'country': 'Germany', 'facility': 'Wilhelm Schütz -Facharzt für HNO Heilkunde', 'geoPoint': {'lat': 50.92149, 'lon': 6.36267}}], 'overallOfficials': [{'name': 'Ralph Mösges, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum der Universität zu Köln'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitop AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}