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Clinical Trial Summary

Primary 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00994851
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date September 2009
Completion date August 2012

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