KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

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)

Timeline

Start

2009-06

Primary completion

2010-04

Completion

2010-04

Drugs

Indications

No indication recorded.