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SENNA+CASSIA

Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.

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

Fase

Fase 3

Estado

Completado

Participantes

96

previstos

Centros

1

Fin del objetivo primario

ago 2012

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Evaluation of the evacuation frequency during the treatment and follow-up period (30 and 45 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria: * Evacuation frequency during the treatment and follow-up period * Consistency of stools during the treatment and follow-up period * Global evaluation, regarding increase in frequency of evacuation and shape of stools. Secondary Objective: * Number of days without evacuation * Proportion of evacuation with pain * Proportion of evacuation with strain * Proportion of evacuation with incomplete sensation * Proportion of blocked stools * Proportion of manual maneuvers to facilitate defecation * Proportion of subjects that adhere to the diet recommended * Proportion of the patients who have to use rescue medication * Level of constipation improvement, according to the patient evaluation * To evaluate clinical tolerability of the study medication by the continuous use * To evaluate the occurrence of 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 (NCT00994851), actualizada en mar 2013.