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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00931853
First received: July 1, 2009
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Constipation
 Drug: SENNA+CASSIA(Naturetti)
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Evaluation of the use of sene extract as rescue medication [ Time Frame: From the baseline to the end of the study (at 30 days) ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931853

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00931853     History of Changes
Other Study ID Numbers: SENCA_L_04392
Study First Received: July 1, 2009
Last Updated: October 16, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Senna Extract
Sennoside A&B
 Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013