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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Constipation

Treatments

Drug: SENNA+CASSIA(Naturetti)

Study type

Interventional

Funder types

Industry

Identifiers

SENCA_L_04392

Details and patient eligibility

About

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.

Enrollment

117 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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.