Status:
COMPLETED
KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges
Lead Sponsor:
Sanofi
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with a sore throat associated or not with an URTI \> or = 24 hours and \< or = 6 days' duration, in the absence of A.Streptococcus\*,
- Evidence of tonsillo-pharyngitis (TPA score \> or = 5) at inclusion,
- With a score of throat soreness \> or = 6 (0-10 ordinal scale),
- With a perception of swollen throat \> or = 60mm (VAS),
- With a global throat pain intensity such as pain at swallowing
- assessed by a VAS \> or = 60 mm.
- \*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.
- Exclusion criteria:
- 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,
- Women known to be pregnant.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT00929877
Start Date
June 1 2009
End Date
April 1 2010
Last Update
May 18 2010
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Cairo, Egypt
2
Sanofi-Aventis Administrative Office
Helsinki, Finland
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Frankfurt, Germany