ConstipationPhase 3NCT00931853
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
A Phase 3 study testing SENNA+CASSIA(Naturetti) in people with Constipation, run by Sanofi at 1 site in Brazil.
Trial summary
Primary Objective: To evaluate the clinical efficacy of Naturetti (jelly sugar free) To test medication on subjects who suffer chronic functional constipation in 30 days use. Secondary Objectives: To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- SENNA+CASSIA(Naturetti)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having chronic functional constipation by ROME IIII criteria
- Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
- Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
- ICF signature
- Be able to understand and agree to undertake the study procedures
- Having no contraindication related to the study drug
- To perform all study visits.
Who cannot join
- Having previous history or current neurological disorder and/or metabolic one
- Having constipation caused by previous surgery
- Having intestinal obstruction including colon/rectum cancer
- Having endocrine disorder as diabetes mellitus
- Having Irritable bowel syndrome or inflammatory bowel disease
- Having multiple sclerosis
Show all 18Show fewer
- Having Parkinsons disease
- Having Hirschsprungs disease and dyssynergy defecation
- Continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker
- Treatment with any other laxative medication other than the rescue medication during the study
- Patients who could not confirm the chronic functional constipation during the phase I study
- Pregnancy or breast feeding woman
- Abnormal laboratory results, or clinical result that shows significant by the Investigator
- Corporeal mass index > 30
- Patients who have participate in other clinical study within 30 days
- Unable to fulfill the questionnaire (diary)
- Any condition that makes impossible to the patient in participates by Investigator opinion.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
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
Primary Objective:
- To evaluate the clinical efficacy of Naturetti (jelly sugar free)
- To test medication on subjects who suffer chronic functional constipation in 30 days use.
Secondary Objectives:
- To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
- To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
- To identify any adverse events related to the study drug
- To identify any drug interaction.
- Conditions
- Constipation
- Being tested
- SENNA+CASSIA(Naturetti)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENNA+CASSIA(Naturetti)Drug
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
| Study group | Role | What they receive |
|---|---|---|
| SENNA + CASSIA (Naturetti) | Experimental | Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days Receives: Drug: SENNA+CASSIA(Naturetti) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the chronic functional constipation symptoms based on the Rome III criteria
Measured: From the baseline to the end of the study (at 30 days)
Secondary outcomes (2)
Evaluation of the stool aspect based on the Bristol Stool Scale
Measured: From the baseline to the end of the study (at 30 days)
Evaluation of the use of sene extract as rescue medication
Measured: From the baseline to the end of the study (at 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaderson Lima, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931853
- Sponsor's protocol ID
- SENCA_L_04392
- Status last verified
- Oct 2012
- First submitted
- 1 Jul 2009
- Last updated
- 17 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00931853
- Acronym / sponsor ID
- SENCA_L_04392
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the clinical efficacy of Naturetti (jelly sugar free)
- To test medication on subjects who suffer chronic functional constipation in 30 days use.
Secondary Objectives:
- To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
- To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
- To identify any adverse events related to the study drug
- To identify any drug interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENNA + CASSIA (Naturetti) | Experimental | Drug: SENNA+CASSIA(Naturetti)Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Having chronic functional constipation by ROME IIII criteria
- Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
- Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
- ICF signature
- Be able to understand and agree to undertake the study procedures
Key exclusion criteria (18 listed)
- Having previous history or current neurological disorder and/or metabolic one
- Having constipation caused by previous surgery
- Having intestinal obstruction including colon/rectum cancer
- Having endocrine disorder as diabetes mellitus
- Having Irritable bowel syndrome or inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENNA+CASSIA(Naturetti)Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days | Drug | SENNA + CASSIA (Naturetti) |
Primary outcome
Measure of the chronic functional constipation symptoms based on the Rome III criteria
Time frame: From the baseline to the end of the study (at 30 days)
2 secondary outcomes
Evaluation of the stool aspect based on the Bristol Stool Scale
Time frame: From the baseline to the end of the study (at 30 days)
Evaluation of the use of sene extract as rescue medication
Time frame: From the baseline to the end of the study (at 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaderson Lima study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SENNA+CASSIA(Naturetti) in people with Constipation, run by Sanofi at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the chronic functional constipation symptoms based on the Rome III criteria (time frame: From the baseline to the end of the study (at 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.