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

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

Sponsors

Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG

Collaborator: University Hospital Muenster

Source Medice Arzneimittel Pütter GmbH & Co KG
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.

Overall Status Completed
Start Date February 1, 2017
Completion Date November 15, 2017
Primary Completion Date July 2, 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
percentage of total responders assessed at Visit 2 (72 hours after first treatment) 72 hours after first treatment
Secondary Outcome
Measure Time Frame
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
Enrollment 321
Condition
Intervention

Intervention Type: Drug

Intervention Name: Benzalkonium Chloride-Benzocaine Topical

Description: Dorithricin = tyrothricin, benzalkonium chloride, benzocaine

Arm Group Label: Dorithricin

Other Name: triple combination

Intervention Type: Drug

Intervention Name: Placebo Oral Tablet

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.

Arm Group Label: Placebo

Other Name: 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

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Location
Facility: doc-HNO for the DoriPha investigators
Location Countries

Germany

Verification Date

October 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dorithricin

Type: Active Comparator

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.

Label: Placebo

Type: Placebo Comparator

Description: 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.

Acronym DoriPha
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

Source: ClinicalTrials.gov