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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
SENNA+CASSIA(Naturetti)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SENNA + CASSIA (Naturetti)

Arm Description

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

Outcomes

Primary Outcome Measures

Measure of the chronic functional constipation symptoms based on the Rome III criteria

Secondary Outcome Measures

Evaluation of the stool aspect based on the Bristol Stool Scale
Evaluation of the use of sene extract as rescue medication

Full Information

First Posted
July 1, 2009
Last Updated
October 16, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00931853
Brief Title
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SENNA + CASSIA (Naturetti)
Arm Type
Experimental
Arm Description
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
Intervention Type
Drug
Intervention Name(s)
SENNA+CASSIA(Naturetti)
Intervention Description
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
Primary Outcome Measure Information:
Title
Measure of the chronic functional constipation symptoms based on the Rome III criteria
Time Frame
From the baseline to the end of the study (at 30 days)
Secondary Outcome Measure Information:
Title
Evaluation of the stool aspect based on the Bristol Stool Scale
Time Frame
From the baseline to the end of the study (at 30 days)
Title
Evaluation of the use of sene extract as rescue medication
Time Frame
From the baseline to the end of the study (at 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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