Clinical trial NCT00929877: KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges
Official title: A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 801
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) after the first intake of study drug.

Secondary Objectives:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:

* the total pain relief summed over 15 to 360min (TOTPAR15-360)
* the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.
* the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min
* the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3

To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:

Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)


Eligibility criteria: 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.

Primary outcomes:
measure: The TOTPAR15-120 which is the sum of each pain relief scale score
timeFrame: measured every 15 minutes during the 2 hours following the first study drug intake
Secondary outcomes:
measure: The TOTPAR15-360 which is the sum of each pain relief scale score
timeFrame: Measured every 15 minutes during the 2 hours following the first study drug intake at study site then every hour up to 6 hours as outpatient.
measure: The global throat pain intensity
timeFrame: assessed every 15 min during 2 hours after the first study drug intake
measure: The morning pain relief scale score
timeFrame: measured in morning of days 1, 2 and 3
measure: The evening pain relief scale score
timeFrame: measured in evening of days 1, 2 and 3
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Frankfurt
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Gilles Perdriset
role: STUDY_DIRECTOR
References: