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

Primary Purpose

Pharyngitis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Benzalkonium Chloride-Benzocaine Topical

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Pharyngitis focused on measuring Dorithricin, Tyrothricin, Benzalkonium chloride, Benzocaine, placebo-controlled, Pharyngitis, sore throat, throat pain, difficulty swallowing, complete responder, lozenge, Non-streptococcal Infections

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

doc-HNO for the DoriPha investigators

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dorithricin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

percentage of total responders assessed at Visit 2 (72 hours after first treatment)

complete resolution of throat pain and difficulty in swallowing at Visit 2

Secondary Outcome Measures

percentage of total responders assessed after 48 hours after first treatment

complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment

percentage of patients with complete resolution of throat pain 72 hours after first treatment

complete resolution of throat pain after 72 hours after first treatment

percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment

complete resolution of difficulty in swallowing after 72 hours after first treatment

Full Information

NCT ID

NCT03323528

First Posted

October 24, 2017

Last Updated

November 24, 2017

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Collaborators

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT03323528

Brief Title

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

Acronym

DoriPha

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

July 2, 2017 (Actual)

Study Completion Date

November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Collaborators

University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngitis

Keywords

Dorithricin, Tyrothricin, Benzalkonium chloride, Benzocaine, placebo-controlled, Pharyngitis, sore throat, throat pain, difficulty swallowing, complete responder, lozenge, Non-streptococcal Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomized allocation of participants to verum or placebo (1:1)

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

investigation: participant, care provider and investigator blinded assessment: participant, care provider and investigator blinded outcome analysis: statistician blinded

Allocation

Randomized

Enrollment

321 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dorithricin

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Benzalkonium Chloride-Benzocaine Topical

Other Intervention Name(s)

triple combination

Intervention Description

Dorithricin = tyrothricin, benzalkonium chloride, benzocaine

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Other Intervention Name(s)

Placebo lozenge

Intervention Description

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.

Primary Outcome Measure Information:

Title

percentage of total responders assessed at Visit 2 (72 hours after first treatment)

Description

complete resolution of throat pain and difficulty in swallowing at Visit 2

Time Frame

72 hours after first treatment

Secondary Outcome Measure Information:

Title

percentage of total responders assessed after 48 hours after first treatment

Description

complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment

Time Frame

48 hours after first treatment

Title

percentage of patients with complete resolution of throat pain 72 hours after first treatment

Description

complete resolution of throat pain after 72 hours after first treatment

Time Frame

72 hours after first treatment

Title

percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment

Description

complete resolution of difficulty in swallowing after 72 hours after first treatment

Time Frame

72 hours after first treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R Ammer, MD, PhD

Organizational Affiliation

MEDICE Arzneimittel Puetter GmbH&Co.KG

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

R Ammer, MD, PhD

Organizational Affiliation

Universtiy hospital Muenster, MedD

Official's Role

Study Director

Facility Information:

Facility Name

doc-HNO for the DoriPha investigators

City

Röthenbach an der Pegnitz

ZIP/Postal Code

90552

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

30329199

Citation

Palm J, Fuchs K, Stammer H, Schumacher-Stimpfl A, Milde J; DoriPha investigators. Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha). Int J Clin Pract. 2018 Dec;72(12):e13272. doi: 10.1111/ijcp.13272. Epub 2018 Oct 17.

Results Reference

derived

Links:

URL

http://www.dorithricin.de

Description

Test product description

Learn more about this trial

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

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