ConstipationPhase 3NCT00994851
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
A Phase 3 study testing SENNA+CASSIA in people with Constipation, run by Sanofi at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Constipation
- What is being tested?
- SENNA+CASSIA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Aug 2012
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
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 (capsules) , considering the following criteria:
Read more
- 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.
- Conditions
- Constipation
- Being tested
- SENNA+CASSIA, placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENNA+CASSIADrug
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
placeboDrug
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
| Study group | Role | What they receive |
|---|---|---|
| SENNA+ CASSIA | Experimental | Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days Receives: Drug: SENNA+CASSIA |
| Placebo | Placebo comparator | Daily administration (capsule) of placebo at bedtime, during 30 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the evacuation frequency during the treatment and follow-up period
Measured: 30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period
Measured: 30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools
Measured: 30 and 45 days
Secondary outcomes (9)
Number of days without evacuation
Measured: 30 days
Proportion of evacuation with pain
Measured: 30 days
Proportion of evacuation with strain
Measured: 30 days
Proportion of evacuation with incomplete sensation
Measured: 30 days
Proportion of blocked stools
Measured: 30 days
Proportion of manual maneuvers to facilitate defecation
Measured: 30 days
Proportion of subjects that adhere to the diet recommended
Measured: 30 days
Proportion of the patients who have to use rescue medication
Measured: 30 days
Level of constipation improvement, according to the patient evaluation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2012
- Study completionAug 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaderson Lima, Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994851
- Sponsor's protocol ID
- SENCA_L_04746
- Status last verified
- Mar 2013
- First submitted
- 13 Oct 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. 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
- NCT00994851
- Acronym / sponsor ID
- SENCA_L_04746
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Oct 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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENNA+ CASSIA | Experimental | Drug: SENNA+CASSIADaily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days |
| Placebo | Placebo comparator | Drug: placeboDaily administration (capsule) of placebo at bedtime, during 30 days |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
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+CASSIAPharmaceutical form: capsule Route of administration: oral Dose regimen: once a day | Drug | SENNA+ CASSIA |
| placeboPharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day | Drug | Placebo |
Primary outcome
Evaluation of the evacuation frequency during the treatment and follow-up period
Time frame: 30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period
Time frame: 30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools
Time frame: 30 and 45 days
9 secondary outcomes
Number of days without evacuation
Time frame: 30 days
Proportion of evacuation with pain
Time frame: 30 days
Proportion of evacuation with strain
Time frame: 30 days
Proportion of evacuation with incomplete sensation
Time frame: 30 days
Proportion of blocked stools
Time frame: 30 days
Proportion of manual maneuvers to facilitate defecation
Time frame: 30 days
Proportion of subjects that adhere to the diet recommended
Time frame: 30 days
Proportion of the patients who have to use rescue medication
Time frame: 30 days
Level of constipation improvement, according to the patient evaluation
Time frame: 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 29 Mar 2013.
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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 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 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 6 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 29 Mar 2013. 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. Some participants in this study may receive a placebo. 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?
Evaluation of the evacuation frequency during the treatment and follow-up period (time frame: 30 and 45 days). The study lists 3 primary outcomes in all. 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 29 Mar 2013.