An observational study in Acute Pharyngitis and Acute Laryngitis, sponsored by Bitop AG. Completed at 8 sites in Germany. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2015-01-09.
Sponsored by Bitop AG · 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.
18 studies on the registry are indexed under Croup; 2 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment with Ectoin Mund- \& Rachenspray 1%
treatment with Emser Pastillen
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
Time frame: Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)
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)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Evaluation of the hoarseness
physician's assessment of the hoarseness of the patient on a 4 point scale (none, mild, moderate, strong)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Dysphagia
physician's assessment of dysphagia of the patient on a 4 point scale (none, mild, moderate, strong)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
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)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week)
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)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
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)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
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)
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in number and type of adverse events
incidence of adverse events and correlation with the therapy
Time frame: Visit 2 (after 3 days) Visit 3 (after 7 days)
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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