Status:
COMPLETED
Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis
Lead Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Collaborating Sponsors:
University Hospital Muenster
Conditions:
Pharyngitis
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benz...
Detailed Description
In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throa...
Eligibility Criteria
Inclusion
- Male and female outpatients aged ≥18 years
- Signed informed consent form
- Clinically diagnosed acute pharyngitis (TPA ≥5)
- Recent onset of symptoms (≤24 hours)
- Pain intensity of ≥8 on an 11-point NRS
- Difficulty in swallowing (100-mm VAS ≥50 mm)
Exclusion
- Patients with strong suspicion of streptococcus A infection (McIsaac score ≥3)
- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- Purulent tonsillitis
- The use of systemic/local antibiotics in the throat area within 7 days prior to screening and during the study
- The use of any systemic analgesics/local analgesics in the throat area (e.g. non-steroidal drugs, \[acetylsalicylic acid \>100 mg\], paracetamol) within 36 hours prior to screening and during the study
- The use of local anaesthetics for treatment of sore throat within 2 days prior to screening and during the study
- The use of any systemic anti-inflammatory drug/local anti-inflammatory drug in the throat area (e.g. glucocorticoids) within 4 weeks prior to screening and during the study
- The use of any other 'sore throat medication' (e.g., lozenges, drops, sprays) or other 'cold medication' that could have interfered with the results of the study within 7 days prior to screening and during the study
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT03323528
Start Date
February 1 2017
End Date
November 15 2017
Last Update
November 28 2017
Active Locations (1)
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1
doc-HNO for the DoriPha investigators
Röthenbach an der Pegnitz, Germany, 90552