Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
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.
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedMarch 29, 2013
March 1, 2013
2.9 years
October 13, 2009
March 28, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Evaluation of the evacuation frequency during the treatment and follow-up period
30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period
30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools
30 and 45 days
Secondary Outcomes (9)
Number of days without evacuation
30 days
Proportion of evacuation with pain
30 days
Proportion of evacuation with strain
30 days
Proportion of evacuation with incomplete sensation
30 days
Proportion of blocked stools
30 days
- +4 more secondary outcomes
Study Arms (2)
SENNA+ CASSIA
EXPERIMENTALDaily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
Placebo
PLACEBO COMPARATORDaily administration (capsule) of placebo at bedtime, during 30 days
Interventions
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jaderson Lima, Study Director
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 14, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
March 29, 2013
Record last verified: 2013-03