STUDY OF EFFICACY AND SAFETY OF V0498 VERSUS PLACEBO IN ACUTE SORE THROAT PAI

• Conditions: Acute sore throat; MedDRA version: 14.1Level: PTClassification code 10049140Term: PharyngotonsillitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-004423-20-LV
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-04
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

•male or female aged at least 18 years old
•patient with an acute sore throat

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 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

•severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
•oro-pharyngeal paresthesia or mycosis
•severely traumatised and/or very severe oromucosal inflammation
•tonsillopharyngectomy
•Peritonsillar abscess
•Hypersensitivity to ibuprofen or other NSAIDs (including bronchospasm) or to excipients
•long term use (= 3 times per week within the last month or regular intake within the last 3 months before randomisation) of anti-inflammatory drugs
•any long-acting or slow release analgesic intake including NSAIDs within 24 hours before randomisation (e.g. piroxicam or naproxen)
•any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
•any paracetamol intake within 6 hours before randomisation
•any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
•any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
•heavy smokers (>20 cigarettes/day)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To compare the analgesic effect of V0498 ibuprofen lozenges versus placebo: <br>•on the Sore Throat Pain Intensity Difference (PID) on swallowing <br>• on the Sum of Pain Intensity Differences on swallowing (SPID) <br>• on the pain responders rate <br>• on the time of onset of the first pain response <br>To assess the local and global tolerability;Main Objective: To compare the effect of V0498 lozenges to that of placebo on the Total Pain Relief (TOTPAR).;Primary end point(s): TOTal PAin Relief (TOTPAR)<br>;Timepoint(s) of evaluation of this end point: Up to 120 min

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sore Throat Pain Intensity Difference (PID) on swallowing <br>Sum of Pain Intensity Differences (SPID) on swallowing <br>Pain Responders on swallowing <br>Time of onset of first pain response <br><br>;Timepoint(s) of evaluation of this end point: Up to 120min and up to Day 4