Acute Pharyngitis Clinical Trial
Official title:
Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
Verified date | January 2015 |
Source | Bitop AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Observational |
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.
Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the
demands of the physician and the instructions for use.
Status | Completed |
Enrollment | 95 |
Est. completion date | December 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years and older |
Eligibility |
Inclusion Criteria: - Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen Exclusion Criteria: - contraindications according to instructions for use |
Observational Model: Case-Crossover, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | HNO Praxis Aachen Brand | Aachen | |
Germany | Norbert Pasch-Facharzt für HNO Heilkunde | Aachen | |
Germany | HNo Praxis Dr. Uta Thieme | Duisburg | |
Germany | Dr. Lenzenhuber-Fachärztin für HNO Heilkunde | Jülich | |
Germany | Wilhelm Schütz -Facharzt für HNO Heilkunde | Jülich | |
Germany | Bey - Facharzt f. HNO Heilkunde | Köln | |
Germany | HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert | Köln | |
Germany | Taufik Shahab -Facharzt für HNO Heilkunde | Köln |
Lead Sponsor | Collaborator |
---|---|
Bitop AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pharyngitis symptom score evaluated by the physician | Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong): swollen palatine tonsils swollen lymph nodes in the throat fever cough |
Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days) | No |
Secondary | Change in patient's general condition evaluated by the physician | Physician's assessment of the general conditions on a 4 point scale (good condition, slightly reduced condition, bad condition, very bad condition) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | No |
Secondary | Change in Evaluation of the hoarseness | physician's assessment of the hoarseness of the patient on a 4 point scale (none, mild, moderate, strong) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | No |
Secondary | Change in Dysphagia | physician's assessment of dysphagia of the patient on a 4 point scale (none, mild, moderate, strong) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | No |
Secondary | Change in efficacy evaluation by the physician | Assessment of the efficacy on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week) | No |
Secondary | Change in efficacy evaluation by the patient | Assessment of the efficacy on a 4 point scale (0_bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | No |
Secondary | Change in Evaluation of the tolerability by the physician | Assessment of the tolerability by the physician on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)) | Yes |
Secondary | Change in Evaluation of the tolerability by the patient | Assessment of the tolerability by the patient on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)) | Yes |
Secondary | Change in number and type of adverse events | incidence of adverse events and correlation with the therapy | Visit 2 (after 3 days) Visit 3 (after 7 days) | Yes |
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