A comparison of effIcacy and safety between the two drugs in patientswith sore throat in order to demonstrate that their efficacy and safety is equivalent

Phase 1

• Conditions: Sore throat associated with upper respiratory infections; MedDRA version: 16.1Level: LLTClassification code 10041368Term: Sore throat NOSSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 16.1Level: PTClassification code 10068319Term: Oropharyngeal painSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-002970-32-SI
• Lead Sponsor: KRKA, tovarna zdravil, d. d., Novo mesto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-21
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified