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SENNA+CASSIA

Phase 3

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

SENNA+CASSIA development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2009

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

SENNA+CASSIA clinical trials

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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Competitive Landscape -Constipation 3 trials

No competing companies are currently tracked in active development for Constipation.
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Frequently asked questions about SENNA+CASSIA

What is SENNA+CASSIA used for?

SENNA+CASSIA is used for the treatment of constipation. It is a small molecule combination product developed by Sanofi for the gastrointestinal therapeutic area. The clinical program has focused on chronic functional constipation, with two completed Phase 3 trials conducted in Brazil.

Who makes SENNA+CASSIA?

SENNA+CASSIA is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this constipation treatment.

What phase is SENNA+CASSIA in?

SENNA+CASSIA is in Phase 3 development. Two Phase 3 trials have been completed, and there are currently no active trials listed for this asset. The completed studies enrolled a total of 213 participants.

What clinical trials is SENNA+CASSIA in?

SENNA+CASSIA has been evaluated in two completed Phase 3 trials: NCT00994851, which studied Cassia Fistula plus Senna Alexandrina Miller in chronic functional constipation and enrolled 96 participants, and NCT00931853, which assessed a sugar-free formulation in the same condition and enrolled 117 participants. Both trials were conducted in Brazil.