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

Constipation Clinical Trial

Official title:

National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994851
• Other study ID #: SENCA_L_04746
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2009
• Last updated: March 28, 2013
• Start date: September 2009
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• SENNA+CASSIA
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
• placebo
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the evacuation frequency during the treatment and follow-up period		30 and 45 days	No
Primary	Evaluation of the stools consistency during the treatment and follow-up period		30 and 45 days	No
Primary	Global evaluation, regarding increase in frequency of evacuation and shape of stools		30 and 45 days	No
Secondary	Number of days without evacuation		30 days	No
Secondary	Proportion of evacuation with pain		30 days	No
Secondary	Proportion of evacuation with strain		30 days	No
Secondary	Proportion of evacuation with incomplete sensation		30 days	No
Secondary	Proportion of blocked stools		30 days	No
Secondary	Proportion of manual maneuvers to facilitate defecation		30 days	No
Secondary	Proportion of subjects that adhere to the diet recommended		30 days	No
Secondary	Proportion of the patients who have to use rescue medication		30 days	No
Secondary	Level of constipation improvement, according to the patient evaluation		30 days	No