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SENNA+CASSIA

Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).

Ensayo de Sanofi en Constipation (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

117

previstos

Centros

1

Fin del objetivo primario

dic 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2010.

Qué mide

Measure of the chronic functional constipation symptoms based on the Rome III criteria (From the baseline to the end of the study (at 30 days)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: * To evaluate the clinical efficacy of Naturetti (jelly sugar free) * To test medication on subjects who suffer chronic functional constipation in 30 days use. Secondary Objectives: * To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related * To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study * To identify any adverse events related to the study drug * To identify any drug interaction.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00931853), actualizada en oct 2012.