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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Constipation

Treatments: Drug: placebo; Drug: SENNA+CASSIA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994851

SENCA_L_04746

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

SENNA+ CASSIA

Experimental group

Description:

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

Treatment:

Drug: SENNA+CASSIA

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo