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SENNA+CASSIA

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment213
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00931853Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).PHASE3 COMPLETED 117 — — Sep 1, 2010Dec 1, 2011Oct 17, 20121 Brazil
NCT00994851Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.PHASE3 COMPLETED 96 — — Sep 1, 2009Aug 1, 2012Mar 29, 20131 Brazil
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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 — 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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