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SENNA+CASSIA

Phase 3

Constipation | Small molecule | Gastrointestinal |Sanofi|Last Updated: Mar 29, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment213

FDA Designations

No designations recorded

Clinical trial landscape

SENNA+CASSIA · 2 trials · 1 indication

Phase 3 2
NCT00931853Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).Constipation
COMPLETED117 Analytics
NCT00994851Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.Constipation
COMPLETED96 Analytics
PHASE3COMPLETED
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
ConstipationUnlock trial analytics
PHASE3COMPLETED
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
ConstipationUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure of the chronic functional constipation symptoms based on the Rome III criteria
From the baseline to the end of the study (at 30 days)
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 Endpoints

Evaluation of the stool aspect based on the Bristol Stool Scale
From the baseline to the end of the study (at 30 days)
Evaluation of the use of sene extract as rescue medication
From the baseline to the end of the study (at 30 days)
Number of days without evacuation
30 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SENNA + CASSIA (Naturetti)EXPERIMENTALDaily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
SENNA+ CASSIAEXPERIMENTALDaily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
PlaceboPLACEBO_COMPARATORDaily administration (capsule) of placebo at bedtime, during 30 days

Interventions

NameTypeDescription
SENNA+CASSIA(Naturetti)DRUGDaily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
SENNA+CASSIADRUGPharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
placeboDRUGPharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
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Eligibility Criteria

Age Range18 Years to 59 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * 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 * ...

Countries:Brazil
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Frequently asked questions about SENNA+CASSIA

What is SENNA+CASSIA used for?

SENNA+CASSIA is an investigational small molecule being developed for the treatment of constipation, specifically chronic functional constipation. It is a combination product containing senna and cassia fistula. The drug is currently in Phase 3 clinical development and has completed two trials in Brazil.

Who makes SENNA+CASSIA?

SENNA+CASSIA is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical development for the treatment of constipation.

What phase is SENNA+CASSIA in?

SENNA+CASSIA is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 clinical trials have been completed, both of which were randomized, double-blind, and placebo-controlled.

What clinical trials is SENNA+CASSIA in?

SENNA+CASSIA has completed two Phase 3 clinical trials. The first, NCT00931853, enrolled 117 participants and evaluated the efficacy and tolerability of the drug in chronic functional constipation. The second, NCT00994851, enrolled 96 participants and also assessed the drug's effect on chronic functional constipation. Both trials were conducted in Brazil.

Is SENNA+CASSIA the same as Cassia fistula plus Senna alexandrina?

Yes, SENNA+CASSIA is the same as the combination of Cassia fistula and Senna alexandrina Miller. The clinical trials for this drug specifically evaluated this combination, with trial titles referencing 'Cassia Fistula Plus Senna Alexandrina Miller' as the active treatment.