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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014