drugset / Trial / NCT00931853

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

NCT00931853 ↗

Phase 3 Completed 117 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary 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.

Timeline

Start
2010-09
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cassia Fistula Unknown — Oral
Subject Senna Alexandrina Miller Unknown — Oral

Indications