Constipation
Conditions
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 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.
Interventions
DRUGSENNA+CASSIA
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
DRUGplacebo
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the evacuation frequency during the treatment and follow-up period | 30 and 45 days |
| Evaluation of the stools consistency during the treatment and follow-up period | 30 and 45 days |
| Global evaluation, regarding increase in frequency of evacuation and shape of stools | 30 and 45 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of evacuation with incomplete sensation | 30 days |
| Proportion of blocked stools | 30 days |
| Proportion of manual maneuvers to facilitate defecation | 30 days |
| Number of days without evacuation | 30 days |
| Proportion of the patients who have to use rescue medication | 30 days |
| Level of constipation improvement, according to the patient evaluation | 30 days |
| Proportion of subjects that adhere to the diet recommended | 30 days |
| Proportion of evacuation with pain | 30 days |
| Proportion of evacuation with strain | 30 days |
Countries
Brazil
Outcome results
None listed