Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis

Launched by MEDICE ARZNEIMITTEL PÜTTER GMBH & CO KG · Oct 24, 2017

Keywords

ClinConnect Summary

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 Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and di...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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