EUCTR2008-008265-36-FR
Active, not recruiting
Phase 1
A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen (as lysinate) lozenges (6.25mg and 12.5mg ) in patients with sore throat” - KRYSTA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- upper respiratory illness : sore throat
- Sponsor
- SANOFI-AVENTIS GROUPE
- Enrollment
- 835
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
Exclusion Criteria
- •?Active gastric or duodenal ulcer
- •?Severe liver disease
- •?Severe kidney disease
- •?Women known to be pregnant
- •?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
Outcomes
Primary Outcomes
Not specified
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