Sore throat associated with upper respiratory infections MedDRA version: 16.1 Level: LLT Classification code 10041368 Term: Sore throat NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.1 Level: PT Classification code 10068319 Term: Oropharyngeal pain System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Septolete total
Pharmaceutical Form: Lozenge
INN or Proposed INN: CETYLPYRIDINIUM CHLORIDE
CAS Number: 123-03-5
Other descriptive name: CETYLPYRIDINIUM CHLORIDE
Concentration unit: mg mi
Sponsors
KRKA, tovarna zdravil, d. d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects with a sore throat associated with upper respiratory trat infection • Onset of sore throat = 6 days • Both sexes, age range 18-65 years • = 4 points on the 10 point Tonsillopharyngitis assessment (TPA) score • Moderate to severe sore throat pain defined as a score = 60 mm on the 100 mm Sore Throat Pain Intensity Scale Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: • Pregnancy or lactation or unreliable contraceptive method • Subjects with any evidence of mouth breathing or coughing which could compromise respiratory function and worsen sore throat • Severe streptococcal tonsillitis assessed by rapid antigen detection test (RADT) • Increased body temperature that needs antipyretic treatment (more than 38.5 C) • Recurrent (chronic) sore throat • Other severe respiratory tract diseases (pneumonia, infectious mononucleosis, asthma or difficulty in breathing, peritonsillar abscess etc.) • Oropharyngeal lesions (tumours, purulent necrotic process, aphtous ulcers, etc.) • Pharmacological therapy with: - Antibiotics currently, - oral antiseptics and demulcents in the form of sprays, gargles, lozenges or drops within 3 h before the initial dose, - short-acting analgesics within 6 hours before the initial dose, - long-acting or slow-release analgesic within 24 hours before the initial dose, - local anaesthetics within 4 hours before the initial dose, - antihistamines within 12 hours before the initial dose, - nasal decongestants, anti-tussives or expectorants including their fixed combinations within 8 hours before the initial dose. • Any chronic disease which requires long-term use of oral analgesics, NSAIDs, antihistamines and local anaesthetics • Previously diagnosed hypersensitivity to benzydamine, other NSAIDs, cetylpyridinium chloride or any other component of study drugs including the rescue medication (paracetamol) • Subject is currently participating in another clinical trial • Excessive alcohol consumption, drug abuse or drug addiction • Subject refuses to participate with the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to demonstrate the equivalence of the treatment effect between test and reference product in terms of the sore throat pain intensity difference at the predefined time point compared to baseline . _WIthin the main objective a superiority of the treatment effect of both test and reference treatment over placebo treatment is to be demonstrated in terms of sore throat pain intensity difference at the predefined time point compared to baseline. ;Secondary Objective: -to assess the safety profile of test in comparison with reference IMP and placebo - to demonstrate similar safety profile in test and reference IMP infections.;Primary end point(s): • Sore throat pain intensity (STPI) difference at 1 hour after the IMP administration (STPID1h). Defined as the mean difference between STPI score at 1 hour after the IMP administration and the baseline STPI score, assessed before the IMP administration at Visit 1. STPI is assessed by visual analogue scale ( VAS);Timepoint(s) of evaluation of this end point: 60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percent of responders after the initial single IMP dose (% RESP). Defined as the share of subjects who respond to the therapy with respect to the total number of subjects taking the same IMP 2. Mean sore throat pain intensity STPI) difference at 2 hours after the IMP administration (STPID2h). Defined as the mean difference between STPI score at 2 hours after the IMP administration and the baseline STPI score, assessed before the IMP administration at Visit 1. STPI is assessed by visual analogue scale ( VAS) 3. Mean sore throat pain intensity STPI) difference at 3 hours after the IMP administration (STPID3h). Defined as the mean difference between STPI score at 3 hours after the IMP administration and the baseline STPI score, assessed before the IMP administration at Visit 1. STPI is assessed by visual analogue scale ( VAS) 4. Total pain relief over the time interval of 15 min to 180 minutes after the IMP administration at Visit 1 (TOTPAR). Defined as mean area under the curve (AUC) of sore throat pain relief (STPAR) scores. These scores are assessed by the STPAR scale. 5. Time to Sore Throat Pain relief (TSTPAR). Defined as the time in minutes to at least 1 point increase on the STPAR scale followed by at least 3-point STPAR score on at least two consecutive measurements. ;Timepoint(s) of evaluation of this end point: 1. 180 min 2. 120 min 3. 180 min 4. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min 5. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min | — |
Countries
Russian Federation, Slovenia
Contacts
Public ContactInfo tocka raziskave
KRKA, tovarna zdravil, d. d., Novo mesto
Outcome results
None listed