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surinabant

Phase 2

Smoking Cessation | Small molecule | Other |Sanofi|Last Updated: Apr 15, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment810
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00432575Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)PHASE2 COMPLETED 810Jan 1, 2007Apr 1, 2008Apr 15, 20098 Belgium, France +6
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Study Endpoints
Primary Endpoints
Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit
during the last four weeks of treatment
Secondary Endpoints
Change from baseline in total body weight
8 weeks
Total score of the Questionnaire of Smoking Urges
8 weeks
Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)
14 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR -
2ACTIVE_COMPARATORsurinabant 2,5 mg/day
3ACTIVE_COMPARATORsurinabant 5 mg/day
4ACTIVE_COMPARATORsurinabant 10 mg/day
Interventions
NameTypeDescription
surinabant (SR147778)DRUGoral administration
placeboDRUGoral administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit. Exclusion Criteria: * Patients with a limited level of motivation. * Other participant in a household enrolled in the study. * Patients who have smoked or ...

Countries:BelgiumFranceGermanyItalyNorwaySpainSwedenSwitzerland
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