Clinical trial NCT00994851: Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluation of the evacuation frequency during the treatment and follow-up period
timeFrame: 30 and 45 days
measure: Evaluation of the stools consistency during the treatment and follow-up period
timeFrame: 30 and 45 days
measure: Global evaluation, regarding increase in frequency of evacuation and shape of stools
timeFrame: 30 and 45 days
Secondary outcomes:
measure: Number of days without evacuation
timeFrame: 30 days
measure: Proportion of evacuation with pain
timeFrame: 30 days
measure: Proportion of evacuation with strain
timeFrame: 30 days
measure: Proportion of evacuation with incomplete sensation
timeFrame: 30 days
measure: Proportion of blocked stools
timeFrame: 30 days
measure: Proportion of manual maneuvers to facilitate defecation
timeFrame: 30 days
measure: Proportion of subjects that adhere to the diet recommended
timeFrame: 30 days
measure: Proportion of the patients who have to use rescue medication
timeFrame: 30 days
measure: Level of constipation improvement, according to the patient evaluation
timeFrame: 30 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima, Study Director
role: STUDY_DIRECTOR
References: