A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) in patients with sore throat” - KRYSTA

• Conditions: upper respiratory illness : sore throat; MedDRA version: 9.1Level: LLTClassification code 10041367Term: Sore throat

• Registration Number: EUCTR2008-008265-36-FI
• Lead Sponsor: SANOFI-AVENTIS GROUPE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-01
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 835

Inclusion Criteria

?Male or female patients aged 18 or over,
?Patients with a sore throat associated or not with a URTI = 24 hours and = 6 days’ duration, in the absence of A.Streptococcus*,
?Evidence of tonsillo- pharyngitis (TPA score = 5) at inclusion,
?With a score of throat soreness = 6 (0-10 ordinal scale),
?With a perception of swollen throat = 60mm (VAS),
?With a global throat pain intensity such as pain at swallowing
?assessed by a VAS = 60 mm,
?Informed consent obtained in writing at the enrolment into the study,
?Ability to understand and comply with study protocol.

*Specific exploration at Inclusion:
- The Score of Mac Isaac will be performed by the investigator.
- Presence of streptococcus will be assessed by a throat swab test
Patients having a positive swab test will not be included.

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

Exclusion Criteria

?Active gastric or duodenal ulcer
?Severe liver disease
?Severe kidney disease
?Women known to be pregnant = 6months
?Breastfeeding women
?Any oral surgery or dental extraction within one week prior to the inclusion and during study treatment
?Any oropharyngeal acute disease that needs an intervention without any delay.
?Any mouth ulcer, gingivitis or periodontitis with a high risk of haemorrages
?Any patients having participated to this or another clinical trial within the previous 30 days.
?Patients having used any local medication containing a local oral anesthetic such as lozenge, spray, mouth rinse or any topical throat treatment within 2 hours before study entry
?Patients with positive throat swab test for A.Streptococcus pharyngitis
?Patients having used analgesics within 4 hours before study entry
?Patients having used any long-acting or slow release analgesics within 12 hours before study entry
?Patients having used any anti inflammatory treatment 8-12 hours before study entry
?Patients having used any anti histaminic 8-12 hours before study entry
?Patients with pharyngeal paresthesia
?Patients with pharyngeal mycosis
?Patients with known history of ketoprofen, aspirin or other NSAID-induced bronchospasm
?Hypersensitivity to ketoprofen or its excipients
?Any disease that could compromise breathing such as bronchopneumonia or asthma
?Evidence of mouth-breathing or uncomfortable coughing
?Any chronic disease that requires a long period anti-inflammatory treatment
?Any chronic disease that requires long term use of anticoagulants or use of anticoagulants or anti-platelet agents one week before study entry

Study & Design

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