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

Active, not recruiting

• Conditions: Sore throat associated with upper respiratory infections; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]; MedDRA version: 14.0Level: LLTClassification code 10041368Term: Sore throat NOSSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.0Level: PTClassification code 10068319Term: Oropharyngeal painSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2011-000278-74-SI
• Lead Sponsor: KRKA, tovarna zdravil, d. d., Novo mesto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 80

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

•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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>;Secondary Objective: - To assess the safety profile of test product in comparison with comparator product and placebo <br><br>- 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