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

Constipation Clinical Trial

Official title:
National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00931853
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date September 2010
Completion date December 2011
View Details
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