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

Phase 3

Completed

• Conditions: Constipation
• Interventions: Drug: SENNA+CASSIA; Drug: placebo

• Registration Number: NCT00994851
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SENNA+ CASSIA	SENNA+CASSIA	Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
Placebo	placebo	Daily administration (capsule) of placebo at bedtime, during 30 days

Primary Outcome Measures

Name	Time	Method
Evaluation of the evacuation frequency during the treatment and follow-up period	30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period	30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools	30 and 45 days

Secondary Outcome Measures

Name	Time	Method
Number of days without evacuation	30 days
Proportion of evacuation with pain	30 days
Proportion of evacuation with strain	30 days
Proportion of evacuation with incomplete sensation	30 days
Proportion of blocked stools	30 days
Proportion of manual maneuvers to facilitate defecation	30 days
Proportion of subjects that adhere to the diet recommended	30 days
Proportion of the patients who have to use rescue medication	30 days
Level of constipation improvement, according to the patient evaluation	30 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇷 Sao Paulo, Brazil