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KETOPROFEN

KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

Ensayo de Sanofi en Dolor.

Más ensayos de: Dolor.

Fase

Fase 3

Estado

Completado

Participantes

801

previstos

Centros

7

Fin del objetivo primario

abr 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2009.

Qué mide

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) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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)

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00929877), actualizada en may 2010.