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

Phase 1

• Conditions: Sore Throat

• Registration Number: EUCTR2009-014401-13-RO
• Lead Sponsor: A.C.R.A.F. S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Last Update Posted: 17 May 2016

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 (Children’s Sore Throat Pain Thermometer” > 120mm);
•willingness of the parentss/legally authorized representative/child to comply with the requirement of the study protocol;
•Written informed consent to the trial signed and dated by the parentss 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