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

NCT ID: NCT03323528

Last Updated: 2017-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-11-15

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.

Conditions

Pharyngitis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Benzalkonium Chloride-Benzocaine Topical

Intervention Type: DRUG

Dorithricin = tyrothricin, benzalkonium chloride, benzocaine

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: 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.

Interventions

Benzalkonium Chloride-Benzocaine Topical

Dorithricin = tyrothricin, benzalkonium chloride, benzocaine

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

triple combination; Placebo lozenge

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: collaborator

Medice Arzneimittel Pütter GmbH & Co KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R Ammer, MD, PhD

Role: STUDY_DIRECTOR

MEDICE Arzneimittel Puetter GmbH&Co.KG

R Ammer, MD, PhD

Role: STUDY_DIRECTOR

Universtiy hospital Muenster, MedD

Locations

doc-HNO for the DoriPha investigators

Röthenbach an der Pegnitz, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 30329199 (View on PubMed)

Related Links

http://www.dorithricin.de

Test product description

Other Identifiers

2016-003962-24

Identifier Type: -

Identifier Source: org_study_id