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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
Sanofi-Aventis Administrative Office
São Paulo, Brazil
Evaluation of the evacuation frequency during the treatment and follow-up period
Time frame: 30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period
Time frame: 30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools
Time frame: 30 and 45 days
Number of days without evacuation
Time frame: 30 days
Proportion of evacuation with pain
Time frame: 30 days
Proportion of evacuation with strain
Time frame: 30 days
Proportion of evacuation with incomplete sensation
Time frame: 30 days
Proportion of blocked stools
Time frame: 30 days
Proportion of manual maneuvers to facilitate defecation
Time frame: 30 days
Proportion of subjects that adhere to the diet recommended
Time frame: 30 days
Proportion of the patients who have to use rescue medication
Time frame: 30 days
Level of constipation improvement, according to the patient evaluation
Time frame: 30 days
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