A comparison of effect and safety between the two drugs in patients with sore throat

A COMPARATIVE EFFICACY AND SAFETY OF CETYLPYRIDINIUM CHLORIDE 1.0 mg/BENZYDAMINE HYDROCHLORIDE 3 mg FIXED COMBINATION LOZENGES IN SUBJECTS WITH SORE THROAT ASSOCIATED WITH UPPER RESPIRATORY TRACT INFECTIONS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000278-74-SI

Enrollment

Registered

2011-07-11

Start date

2011-07-11

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Sore throat associated with upper respiratory infections MedDRA version: 14.0 Level: LLT Classification code 10041368 Term: Sore throat NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: PT Classification code 10068319 Term: Oropharyngeal pain System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Septolete total Product Code: L59136 Pharmaceutical Form: Lozenge INN or Proposed INN: BENZYDAMINE CAS Number: 642-72-8 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Subjects with a sore throat associated with URTI • Onset of sore throat = 6 days • Both sexes, age range 18-65 years • = 3 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: • Pregnancy and lactation • Subjects with any evidence of mouth breathing or coughing which could compromise respiratory function and worsen sore throat • Severe streptococcal tonsillitis (8 points or more of the TPA and positive rapid antigen detection test) • 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, - 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 anesthetics 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 anesthetics • Previously diagnosed hypersensitivity to benzydamine, other NSAIDs, cetylpyridinium chloride or any other component of study drugs • 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 assess the parameters of the treatment effect of test product in comparison with comparator product and placebo in subjects with sore throat associated with upper respiratory tract infections. ;Secondary Objective: - To assess the safety profile of test product in comparison with comparator product and placebo - To evaluate the adequacy of efficacy and safety variables for the application in further studies with the test product;Primary end point(s): Total Pain Relief (TOTPAR 3-180min) assessed by the pain relief score (questionnaire);Timepoint(s) of evaluation of this end point: 180 min	—

Measure

Time frame

Main Objective: - To assess the parameters of the treatment effect of test product in comparison with comparator product and placebo in subjects with sore throat associated with upper respiratory tract infections. ;Secondary Objective: - To assess the safety profile of test product in comparison with comparator product and placebo - To evaluate the adequacy of efficacy and safety variables for the application in further studies with the test product;Primary end point(s): Total Pain Relief (TOTPAR 3-180min) assessed by the pain relief score (questionnaire);Timepoint(s) of evaluation of this end point: 180 min

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Secondary

Measure	Time frame
Secondary end point(s): 1 Percent of maximal Total Pain relief (%max TOTPAR): the ratio between observed TOTPAR 3-180min and the highest possible TOTPAR3-180min score 2 Percent of responders (% RESP): the share of subjects who will reach %max TOTPAR 3-180min of at least 33 %. 3 Sore Throat Pain Relief (STPAR): assessed by sore throat pain relief (STPAR) scale 4 Time to Sore Throat Pain relief (TSTPAR): the time in minutes to at least 1 point increase on the STPAR scale 5 Sore Throat Pain Intensity Differences (STPID 3-180min): calculation of area under curve (AUC) of pain intensity differences with respect to baseline, assessed by visual analogue scale (VAS) 6 Sore Throat Pain Intensity (STPI): assessed by visual analogue scale (VAS) 7 Swollen Throat Differences (STD15-180min): calculation of AUC of symptoms of swollen throat differences with respect to baseline, assessed by VAS 8 Swollen Throat (ST): assessed by VAS 9 Difficulty in swallowing differences (DSD 15-180min): calculation of AUC of swallowing difficulty differences with respect to baseline, assessed by VAS 10 Difficulty in swallowing (DS): assessed by VAS ;Timepoint(s) of evaluation of this end point: Variables 1, 2, 4, 5, 7 and 9: at 180 min after the IMP application Variables 3 and 6: at 3, 6, 9, 12, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min after the IMP application Variables 8 and 10: at 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min after the IMP application	—

Measure

Time frame

Secondary end point(s): 1 Percent of maximal Total Pain relief (%max TOTPAR): the ratio between observed TOTPAR 3-180min and the highest possible TOTPAR3-180min score 2 Percent of responders (% RESP): the share of subjects who will reach %max TOTPAR 3-180min of at least 33 %. 3 Sore Throat Pain Relief (STPAR): assessed by sore throat pain relief (STPAR) scale 4 Time to Sore Throat Pain relief (TSTPAR): the time in minutes to at least 1 point increase on the STPAR scale 5 Sore Throat Pain Intensity Differences (STPID 3-180min): calculation of area under curve (AUC) of pain intensity differences with respect to baseline, assessed by visual analogue scale (VAS) 6 Sore Throat Pain Intensity (STPI): assessed by visual analogue scale (VAS) 7 Swollen Throat Differences (STD15-180min): calculation of AUC of symptoms of swollen throat differences with respect to baseline, assessed by VAS 8 Swollen Throat (ST): assessed by VAS 9 Difficulty in swallowing differences (DSD 15-180min): calculation of AUC of swallowing difficulty differences with respect to baseline, assessed by VAS 10 Difficulty in swallowing (DS): assessed by VAS ;Timepoint(s) of evaluation of this end point: Variables 1, 2, 4, 5, 7 and 9: at 180 min after the IMP application Variables 3 and 6: at 3, 6, 9, 12, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min after the IMP application Variables 8 and 10: at 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min after the IMP application

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Countries

Russian Federation, Slovenia

Contacts

Public ContactInfo tocka raziskave

KRKA, tovarna zdravil, d. d., Novo mesto

marko.boh@krka.biz0038614751489

Outcome results

None listed

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