Study comparing the effects of two different dosage forms (mouth spray and lozenges) of the same medication (benzydamine) in children aged 6-12 years with sore throat.
- Conditions
- acute sore throatMedDRA version: 23.1Level: LLTClassification code 10041367Term: Sore throatSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2022-003285-20-HU
- Lead Sponsor
- Angelini Pharma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 356
1.Male and female patients (aged 6-12 years, limits included);
2.Recent onset (=3 days) of sore throat;
3.Diagnosis of tonsillopharyngitis confirmed by a score =5 on TPA;
4.A score of at least two points (equal to 1 face) in the WBS score;
5.Signed and dated written Informed Consent: The ICF for participation in the study and consent to data processing will be signed by the parents/legal guardian while the child will sign the assent form only.
Are the trial subjects under 18? yes
Number of subjects for this age range: 356
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Known hypersensitivity to benzydamine hydrochloride or its excipients;
2.Phenylketonuria;
3.Clinically significant abnormalities at physical examination based on Investigator’s judgement;
4.Intolerance to acetylsalicylic acid or other NSAIDS;
5.History or diagnosis of asthma;
6.Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
7.Severe coughing which causes throat discomfort (Investigator judgement);
8.Purulent plaques on the tonsils;
9.Any inhaled therapy in the previous week before the first IMP administration;
10.Use of antibiotics for an acute disease in the 7 days before randomization; any sustained release analgesic within 24 hours of IMP administration; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of IMP administration;
11.Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours prior to IMP administration;
12.Participation to a clinical trial within 3 months prior to the inclusion in the
study;
13.Parents/legal guardian, who are unable to comprehend the full nature and
purpose of the study and to comply with the requirements of the study;
14.SARS-CoV2 positivity;
15.Female patients of child-bearing potential, who are pregnant;
16. Any other diseases that present sore throat as concomitant symptoms.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method