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SMS995

Phase 1

Irritable Bowel Syndrome (IBS) | Small molecule | Gastrointestinal |Novartis AG|Last Updated: May 8, 2009

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_CONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00584298Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using OctreotidePHASE1 COMPLETED 50Jan 1, 2008 -May 8, 20097 United States, Canada +2
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Study Endpoints
Primary Endpoints
- 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol.
throughout the study
Secondary Endpoints
- colorectal compliance
throughout the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SMS995DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * A positive diagnosis of IBS. * Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local * contraception. * Able to communicate well with the investigator, to understand and ...

Countries:United StatesCanadaSwedenUnited Kingdom
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