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

NCT ID: NCT00994851

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-08-31

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SENNA+ CASSIA

Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days

Group Type: EXPERIMENTAL

SENNA+CASSIA

Intervention Type: DRUG

Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day

Placebo

Daily administration (capsule) of placebo at bedtime, during 30 days

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

Interventions

SENNA+CASSIA

Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day

Intervention Type: DRUG

placebo

Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaderson Lima, Study Director

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

SENCA_L_04746

Identifier Type: -

Identifier Source: org_study_id