Back to resultsEvaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
Primary Purpose
Constipation
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
SENNA+CASSIA
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SENNA+ CASSIA
Placebo
Arm Description
Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
Daily administration (capsule) of placebo at bedtime, during 30 days
Outcomes
Primary Outcome Measures
Evaluation of the evacuation frequency during the treatment and follow-up period
Evaluation of the stools consistency during the treatment and follow-up period
Global evaluation, regarding increase in frequency of evacuation and shape of stools
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00994851
Brief Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENNA+ CASSIA
Arm Type
Experimental
Arm Description
Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily administration (capsule) of placebo at bedtime, during 30 days
Intervention Type
Drug
Intervention Name(s)
SENNA+CASSIA
Intervention Description
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
Primary Outcome Measure Information:
Title
Evaluation of the evacuation frequency during the treatment and follow-up period
Time Frame
30 and 45 days
Title
Evaluation of the stools consistency during the treatment and follow-up period
Time Frame
30 and 45 days
Title
Global evaluation, regarding increase in frequency of evacuation and shape of stools
Time Frame
30 and 45 days
Secondary Outcome Measure Information:
Title
Number of days without evacuation
Time Frame
30 days
Title
Proportion of evacuation with pain
Time Frame
30 days
Title
Proportion of evacuation with strain
Time Frame
30 days
Title
Proportion of evacuation with incomplete sensation
Time Frame
30 days
Title
Proportion of blocked stools
Time Frame
30 days
Title
Proportion of manual maneuvers to facilitate defecation
Time Frame
30 days
Title
Proportion of subjects that adhere to the diet recommended
Time Frame
30 days
Title
Proportion of the patients who have to use rescue medication
Time Frame
30 days
Title
Level of constipation improvement, according to the patient evaluation
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima, Study Director
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
We'll reach out to this number within 24 hrs