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

November 24, 2017 updated by: Medice Arzneimittel Pütter GmbH & Co KG

A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed.

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Röthenbach an der Pegnitz, Germany, 90552
        • doc-HNO for the DoriPha investigators

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dorithricin

Dorithricin throat lozenges is a fixed combination of three active substances: Benzalkonium Chloride-Benzocaine Topical plus tyrothricin. Lozenge has to be sucked slowly until it fully dissolves in the mouth and dosed up to 8 lozenges per day. Test product without mint oil.

Intervention: The initial dose is administered at the study site. Patients administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
Drug: Benzalkonium Chloride-Benzocaine Topical
Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
Other Names:
  • triple combination
Placebo Comparator: Placebo

Placebo Oral Tablet is taken orally. Placebo consists of a lozenge with matched appearance and the same excipients as those of the Dorithricin lozenge. The initial dose (2 lozenges simultaneously) is administered at the study site.

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.
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.

Other Names:
  • Placebo lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of total responders assessed at Visit 2 (72 hours after first treatment)
Time Frame: 72 hours after first treatment
complete resolution of throat pain and difficulty in swallowing at Visit 2
72 hours after first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of total responders assessed after 48 hours after first treatment
Time Frame: 48 hours after first treatment
complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment
48 hours after first treatment
percentage of patients with complete resolution of throat pain 72 hours after first treatment
Time Frame: 72 hours after first treatment
complete resolution of throat pain after 72 hours after first treatment
72 hours after first treatment
percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment
Time Frame: 72 hours after first treatment
complete resolution of difficulty in swallowing after 72 hours after first treatment
72 hours after first treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Collaborators

University Hospital Muenster

Investigators

  • Study Director: R Ammer, MD, PhD, MEDICE Arzneimittel Puetter GmbH&Co.KG
  • Study Director: R Ammer, MD, PhD, Universtiy hospital Muenster, MedD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

July 2, 2017

Study Completion (Actual)

November 15, 2017

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-003962-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

study protocol, statistical analysis plan, informed consent form, clinical study report are shared with all 26 recruited centers of the DoriPha investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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