A double-blind, randomized, placebo-controlled, parallel-group study comparing safety and efficacy of Dorithricin® lozenges with placebo in the symptomatic treatment of patients with acute throat infectio
- Conditions
- Acute pharyngitisTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-003111-38-DE
- Lead Sponsor
- Medice Arzneimittel Pütter GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
•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)
•Moderate or severe pain intensity (11-point numerical scale =6)
•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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
• 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 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
•Major wounds of the mouth and throat
•Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
•Severe neurologic and/or psychiatric disorders
•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 patients with complete resolution of throat pain and difficulty in swallowing 48 hrs and 72 hrs after first application of treatment.<br>;Timepoint(s) of evaluation of this end point: At Visit 2 / Day 4 / T72 hrs. Analysis will be done after last patient last visit, data cleaning, data base lock and unblinding.
- Secondary Outcome Measures
Name Time Method