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

NCT00929877 Phase 3 COMPLETED

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)

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	801
Start date	2009-06
Completion	2010-04

Conditions

• Pain

Interventions

• KETOPROFEN(RP19583)
• KETOPROFEN(RP19583)
• Placebo

Primary outcomes

• The TOTPAR15-120 which is the sum of each pain relief scale score — measured every 15 minutes during the 2 hours following the first study drug intake

Countries

Egypt, Finland, France, Germany, Mexico, Russia, Spain