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 Details — Status: Completed

Administrative data

• NCT number: NCT00931853
• Other study ID #: SENCA_L_04392
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2009
• Last updated: October 16, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• SENNA+CASSIA(Naturetti)
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Evaluation of the stool aspect based on the Bristol Stool Scale		From the baseline to the end of the study (at 30 days)	No
Secondary	Evaluation of the use of sene extract as rescue medication		From the baseline to the end of the study (at 30 days)	No