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

NCT03323528 | Completed Phase 4 DMC

• 1 other identifier: 2016-003962-24
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharyngitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  72 hours after first treatment

Secondary Outcomes (3)

• percentage of total responders assessed 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

  72 hours after first treatment

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

  72 hours after first treatment

Study Arms (2)

Dorithricin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Benzalkonium Chloride-Benzocaine Topical DRUG

Dorithricin = tyrothricin, benzalkonium chloride, benzocaine

Also known as: triple combination

Dorithricin

Placebo Oral Tablet DRUG

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.

Also known as: Placebo lozenge

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medice Arzneimittel Pütter GmbH & Co KG: lead
• University Hospital Muenster: collaborator

Study Sites (1)

doc-HNO for the DoriPha investigators

Röthenbach an der Pegnitz, 90552, Germany

Location

Related Publications (1)

• 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.

  PMID: 30329199 DERIVED

Related Links

• Test product description

MeSH Terms

Conditions

Pharyngitis; Deglutition Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• R Ammer, MD, PhD

  MEDICE Arzneimittel Puetter GmbH&Co.KG

  STUDY DIRECTOR

• R Ammer, MD, PhD

  Universtiy hospital Muenster, MedD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: investigation: participant, care provider and investigator blinded assessment: participant, care provider and investigator blinded outcome analysis: statistician blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: February 1, 2017
• Primary Completion: July 2, 2017
• Study Completion: November 15, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)