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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00994851
First received: October 13, 2009
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention Phase
Constipation
Drug: SENNA+CASSIA
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evaluation of the evacuation frequency during the treatment and follow-up period [ Time Frame: 30 and 45 days ] [ Designated as safety issue: No ]
  • Evaluation of the stools consistency during the treatment and follow-up period [ Time Frame: 30 and 45 days ] [ Designated as safety issue: No ]
  • Global evaluation, regarding increase in frequency of evacuation and shape of stools [ Time Frame: 30 and 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days without evacuation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of evacuation with pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of evacuation with strain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of evacuation with incomplete sensation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of blocked stools [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of manual maneuvers to facilitate defecation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of subjects that adhere to the diet recommended [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of the patients who have to use rescue medication [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Level of constipation improvement, according to the patient evaluation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: September 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SENNA+ CASSIA
Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
Drug: SENNA+CASSIA
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
Placebo Comparator: Placebo
Daily administration (capsule) of placebo at bedtime, during 30 days
Drug: placebo
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic functional constipation present, diagnosed by Rome III criteria.
  • Present in most evacuations intestinal feces classified as Type 1 or 2 by the classification of Bristol.
  • Women sexually active and reproductive age, using more than three months effective contraceptive method.
  • Concordance, level of education and consciousness enough to cooperate with the completion of all study procedures.
  • No contraindication to the use of medication in the study.
  • Availability to attend all the visits of the study evaluation.

Exclusion criteria:

  • History or presence of neurological disorders and / or metabolism.
  • Persons with constipation caused by previous surgery.
  • Presence of obstructive lesions in the gastrointestinal tract, including colorectal cancer.
  • Irritable bowel syndrome or inflammatory bowel disease.
  • Multiple Sclerosis
  • Parkinson's disease
  • Other abnormalities such as Hirschsprung's disease and Defecation Dissinrgica.
  • Heart disease and / or hypertension.
  • Continuous use of medication such as analgesics, anti-cholinergic (anti-histamines, antispasmodics, antidepressants, anti-psychotics), supplements with iron or aluminum, Opiates, Anti-hypertensive, CALCIUM CHANNEL BLOCKERS Preganglionic and blockers.
  • Use of any other except the laxative rescue medication during the study.
  • Subjects who do not confirm the diagnosis of ICFC during Phase I of the study.
  • Pregnant or breast-feeding period.
  • Laboratory tests outside the normal range, or the result is assessed as clinically significant by the Investigator.
  • Body Mass Index (BMI) over 30.
  • Participation in another clinical study within 30 days.
  • Do not fill the correct Diary
  • Any condition that in view of the researcher impossible the Subject to participate in the study.

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: NCT00994851

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00994851     History of Changes
Other Study ID Numbers: SENCA_L_04746
Study First Received: October 13, 2009
Last Updated: March 28, 2013
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 April 15, 2014