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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014401-13-IT

Enrollment

180

Registered

2009-10-07

Start date

2009-12-15

Completion date

Unknown

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sore-throat MedDRA version: 9.1 Level: LLT Classification code 10057868

Interventions

Trade Name: TANTUM VERDE NEBUL.*NEB.30ML Pharmaceutical Form: Oromucosal solution INN or Proposed INN: benzydamine CAS Number: 132-69-4 Current Sponsor code: AF864 Concentration unit: % percent Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026