Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Senna Extract; Sennoside A&B

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.