Status:
COMPLETED
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
Lead Sponsor:
Sanofi
Conditions:
Constipation
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00994851
Start Date
September 1 2009
End Date
August 1 2012
Last Update
March 29 2013
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
São Paulo, Brazil