acute sore throat
Conditions
Interventions
Trade Name: Tantum Verde 0,30% oromucosal spray, solution
Product Name: Tantum Verde 0,30% oromucosal spray, solution
Pharmaceutical Form: Oromucosal spray, solution
Trade Name: Tantum Verde P 3 mg
Sponsors
Angelini S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and female patients (aged 18 - 75 years, limits included) with recent onset (=3 days) of sore throat and a diagnosis of tonsillopharyngitis confirmed by: a. Presence of at least one symptom of URTI in the previous 24 h on the URTI questionnaire; b. Sore throat pain intensity score = 60 mm on Sore Throat Pain Intensity Scale (STPIS); c. A score = 5 on Tonsillo-Pharingytis Assessment (TPA); 2. Women of childbearing potential or with no menses for a period =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to benzydamine or its excipients; 2. Phenylketonuria; 3. Clinically significant abnormalities at physical examination and vital signs; 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. Mouth breathing due to nasal congestion which causes throat drying; 8. Severe coughing which causes throat discomfort; 9. Purulent plaques on the tonsils; 10. Any inhaled therapy in the previous week before the first drug administration; 11. Use of antibiotics for an acute disease in the 7 days before randomisation (chronic antibiotic use, such as for acne, is acceptable); any sustained release analgesic within 24 hours of administration of study medication; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of administration of study medication; 12. Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours of administration of study medication; 13. Women during pregnancy or lactation period; 14. Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc); 15. Participation to a clinical trial within 3 months prior to the inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of benzydamine hydrochloride (spray or lozenges), in sore throat pain relief, at 2 minutes (T2 min) after a single dose administration.;Secondary Objective: •to add. evaluate if a first perceived sore throat relief is experienced already at 1 min, after a single-dose IMP spray or lozenges; •to evaluate the meaningful sore throat relief after a single-dose of IMP spray or lozenges, at timepoints (min): T5;T10;T15;T30;T60; T120; •to assess the sore throat relief up to T240 min after a single-dose of IMP spray or lozenges; •to assess the effect of IMP spray or lozenges on difficulty swallowing and swollen throat at timepoints (min): T5;T10;T15;T30;T60;T120; •to describe any differences from baseline (and betw. 2 IMP treatments) in terms of effect of IMP (spray or lozenges) on different characteristics of ST pain and discomfort after 60 min,120 min; •to assess the sore throat intensity across the study, the pharyngeal inflammation status and the Patient Satisfaction for the received medication, at the end of the treatment; •to assess the safety of IMP spray or lozenges when locally applied up to a 7 days treatment period. ;Primary end point(s): Primary endpoint: percentage of responders defined as patients reported at least a “slight relief” (STRRS score =1) at 2 minutes after the first application of benzydamine hydrochloride 0.3% spray or benzydamine hydrochloride 3mg lozenges. The quantification of pain relief obtained will be assessed by completing the STRRS (Sore Throat Relief Rating Scale). A “slight relief” in STRRS (score=1) will be considered as the first perceived pain relief. ;Timepoint(s) of evaluation of this end point: 2 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: the secondary endpoints of the study will be: 1) percentage of patients recording a first perceived pain relief assessed at T1 min. A “slight relief” in STRRS (score=1) will be considered as the first perceived pain relief; 2) percentage of patients recording a meaningful sore throat relief assessed at T5 min, T10 min, T15 min, T30 min, T60 min and T120 minutes after a single dose administration. A “meaningful sore throat relief” is considered as a score = 3 (moderate relief) in the STRRS; 3) the change from 1 minute up to 4 hours post-dose (T1 min; T2 min; T5min; T10min; T15min; T30min; T60min; T120min; T240min) in STRRS; 4) the change from baseline up to 2 hours post-dose (T0; T5 min; T10 min; T15 min; T30 min; T60 min; T120 min) in DSS (Difficulty Swallowing Scale) and the SwoTS (Swollen Throat Scale); 5) the change from baseline at T60 and 120 minutes post-dose in QuaSTI (Qualities of Sore Throat Index); 6) the change in sore throat pain intensity from baseline up to 7 days of treatment through the STPIS assessment (Sore Throat Pain Intensity Scale); 7) the treatment effect at the end of the treatment period through a TPA (Tonsillo-Pharyngitis Assessment); 8) the patient global treatment evaluation at the end of the treatment period through a PSQ (Patient Satisfaction Questionnaire); 9) safety assessment. ;Timepoint(s) of evaluation of this end point: 1) 1 minute 2) 120 minutes 3) 240 minutes 4) 120 minutes 5) 120 minutes 6) 7 days 7) 7 days 8) 7 days 9) 7 days | — |
Countries
Hungary, Poland, Russian Federation
Contacts
Public ContactStudy Manager
Angelini S.p.A.
Outcome results
None listed