acute pharyngitis and tonsillitis which do not require antbiotic therapy
Conditions
Interventions
Product Name: AAR1
Product Code: AAR1
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: BENZYDAMINE HYDROCHLORIDE
CAS Number: 132694
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
Zaklady Farmaceutyczne "UNIA" Spóldzielnia Pracy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute pharyngitis or tonsillitis who do not require antibiotic therapy 2. Symptoms duration no longer than 72 hours 3. Symptoms score not less than 6 4. Patients aged 18 to 65 years 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with: a. chronic or recurrent pharyngitis b. oral aphthae c. serious decompensate systemic disease d. low immunity e. active, massive dental caries f. allergic to any of product compounds g. asthma h. alimentary tract inflammation i. stomach or duodenal ulceration j. esophageal varices k. kidney or liver insufficiency 2. Patients treated with: a. antibiotic up to 14 days before visit 1 b. systemic or inhalant corticosteroids up to 28 days before visit 1 c. another interventions during current acute pharyngitis or tonsillitis 3. Patients who: a. were included to another trial or were given another investigated medication up to 30 days before visit 1 b. previously included to AAR1 trial c. are investigators, investigators' team members or their families 4. Patients with streptococcal complications 5. Pregnant or breast feeding patients 6. Patients chronically staying in chemical vapors’ or dust polluted environment 7. Patients smoking 8. Patients addicted to drugs, alcohol or another substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To indicate that new benzydamine hydrochloride product used locally 4 to 6 times daily is equally effective as reference product in acute pharyngitis or tonsillitis in adult patients ;Secondary Objective: To indicate that acute pharyngitis or tonsillitis threatment with new benzydamine hydrochloride product is well tolerated and the risk of adverse drug reactions is minimal ;Primary end point(s): 1. Total symptoms score on the day 7 (+/-1) 2. Adverse drug reaction frequency | — |
Countries
Poland
Outcome results
None listed