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.

Phase 1

• Conditions: Acute Pharyngitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-003962-24-DE
• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

•male and female outpatients aged =18 years
•signed informed consent form
•clinically diagnosed acute pharyngitis (Tonsillo-Pharyngitis Assessment (TPA) =5)
•recent onset of symptoms (=24 hours)
•pain intensity of =8 on a 11-point numeric rating scale
•difficulty in swallowing (100-mm VAS =50 mm)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

Exclusion Criteria

•patients with strong suspicion of streptococcus A infection (McIsaac Score =3)
•another acute episode of pharyngitis within the last 7 days prior to screening (the current acute pharyngitis which started within the last 24 hours is not meant)
•positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
•purulent tonsillitis
•severe inflammations of the throat or throat pain that are accompanied by high fever (= 38,5°C, oral (sublingual)), headache, nausea and/or vomiting
•the use of systemic antibiotics / local antibiotics in the throat area during the study and within the previous 7 days prior to screening
•the use of any systemic analgesics / local analgesics in the throat area (e.g. non-steroidal drugs, ASA (> 100 mg), paracetamol) during the study or within the previous 36 hours prior to screening
•the use of any systemic anti-inflammatory drug / local anti-inflammatory drug in the throat area (e.g. glucocorticoids) during the study or within the previous 4 weeks prior to screening
•the use of local anesthetics for treatment of sore throat during the study or within the previous 2 days prior to screening
•the use of any other ‘sore throat medication’ (e.g. lozenges, drops, sprays) or other cold medication” that could interfere the study results during the study and within the previous 7 days prior to screening
•the use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to screening
•major wounds of the mouth and throat
•immunodeficiency disorders (e.g. organ transplantation, HIV infection)
•severe neurologic and/or psychiatric disorders (including acute depressive mood / acute episode of depression)
•malignant ENT disorders within the previous 5 years
•known hypersensitivity to any of the ingredients of the study medication
•fructose intolerance
•women of child-bearing potential who do not use a highly effective method of contraception, that is the case when the Pearl Index of the contraceptive measure is =1
•pregnancy and lactation
•participation in another clinical study during the study and within the previous 30 days prior to screening
•presence of drug or alcohol abuse
•persons who are institutionalized by court order or regulatory action
•patients, who are members of the staff of the study center, staff of the sponsor or involved Clinical Research Organization (CRO), the investigator him- / herself or close relatives of the investigator
•legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety and efficacy of Dorithricin® Halstabletten Classic (lozenges);Secondary Objective: Not applicable;Primary end point(s): The primary endpoint variable is defined as the percentage of total responders assessed at Visit 2 (approx. 72 hrs after first application of treatment).;Timepoint(s) of evaluation of this end point: At Visit 2 / T72 hrs. Analysis will be done after last patient last<br>visit, data cleaning, data base lock and unblinding.