Efficacy and safety of an alcohol-free formulation of 0.15% benzydamine spray in children with sore throat. Randomized, double blind, placebo-controlled study - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Patients may be enrolled under the following circumstances: male and female outpatients, school children 6-12 years old; objective findings that confirm the sore throat diagnosis (Tonsillo-Pharyngitis Scale > 6 points); onset of sore throat symptoms within 7 days; moderate-to-severe sore throat (Childrens Sore Throat Pain Thermometer > 120mm); willingness of the parents/legally authorized representative/child to comply with the requirement of the study protocol; Written informed consent to the trial signed and dated by the parents or legal representative according to the local regulations
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Exclusion Criteria

Patients cannot enter the trial under the following circumstances: past/present history of hypersensitivity reaction to benzydamine or its components, or positive history for drug allergy, in particular to NSAIDs; any concomitant disease that compromises breathing; use of any throat lozenge, oral rinse, menthol-containing products within 2 hours of study entry, any cold medication (i.e., decongestionant, antihistamine, expectorants, antitussives) within the past 8 hours, analgesic, antipyretic within 6 hours; chronic use of NSAIDs; inability by the parents/legally authorized representative/child to comprehend or correctly use the pain rating scales; patient participating in another device or clinical trial in the previous 4 weeks or previously enrolled in this trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary: evaluation of the analgesic activity of 0.15% benzydamine spray in single administration compared to placebo.;Secondary Objective: Secondary: i. evaluation of the 0.15% benzydamine spray tolerability and safety in single administration compared to placebo; ii. evaluation of the 0.15% benzydamine spray tolerability and safety after a 3-day administration period;Primary end point(s): The study primary endpoint will be the analgesic efficacy of a single administration (4 nebulizations) of 0.15% benzydamine compared to placebo, assessed in a 90 min period.

Secondary Outcome Measures

Name	Time	Method

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