Status:
COMPLETED
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
Lead Sponsor:
Sanofi
Conditions:
Constipation
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
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 Objective...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00931853
Start Date
September 1 2010
End Date
December 1 2011
Last Update
October 17 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
São Paulo, Brazil