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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: SENNA+CASSIA(Naturetti)

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Having chronic functional constipation by ROME IIII criteria
• Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
• Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
• ICF signature
• Be able to understand and agree to undertake the study procedures
• Having no contraindication related to the study drug
• To perform all study visits.

Exclusion criteria:

• Having previous history or current neurological disorder and/or metabolic one
• Having constipation caused by previous surgery
• Having intestinal obstruction including colon/rectum cancer
• Having endocrine disorder as diabetes mellitus
• Having Irritable bowel syndrome or inflammatory bowel disease
• Having multiple sclerosis
• Having Parkinsons disease
• Having Hirschsprungs disease and dyssynergy defecation
• Continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker
• Treatment with any other laxative medication other than the rescue medication during the study
• Patients who could not confirm the chronic functional constipation during the phase I study
• Pregnancy or breast feeding woman
• Abnormal laboratory results, or clinical result that shows significant by the Investigator
• Corporeal mass index > 30
• Patients who have participate in other clinical study within 30 days
• Unable to fulfill the questionnaire (diary)
• Any condition that makes impossible to the patient in participates by Investigator opinion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENNA + CASSIA (Naturetti); Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days	Drug: SENNA+CASSIA(Naturetti); Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure of the chronic functional constipation symptoms based on the Rome III criteria	From the baseline to the end of the study (at 30 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the stool aspect based on the Bristol Stool Scale	From the baseline to the end of the study (at 30 days)
Evaluation of the use of sene extract as rescue medication	From the baseline to the end of the study (at 30 days)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Estimate): October 17, 2012
• Last Update Submitted That Met QC Criteria: October 16, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Anatomical; Fistula; Constipation
• Other Study ID Numbers: SENCA_L_04392