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

NCT03323528 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2017-11-28

No results posted yet for this study

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 benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.

Conditions

  • Pharyngitis

Interventions

DRUG

Benzalkonium Chloride-Benzocaine Topical

Dorithricin = tyrothricin, benzalkonium chloride, benzocaine

DRUG

Placebo Oral Tablet

Placebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge. Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.

Sponsors & Collaborators

  • University Hospital Muenster

    collaborator OTHER

  • Medice Arzneimittel Pütter GmbH & Co KG

    lead INDUSTRY

Principal Investigators

  • R Ammer, MD, PhD · MEDICE Arzneimittel Puetter GmbH&Co.KG

  • R Ammer, MD, PhD · Universtiy hospital Muenster, MedD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-07-02
Completion
2017-11-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323528 on ClinicalTrials.gov