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SS-RBX

Phase 2

Urinary Incontinence, Stress | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Jun 1, 2011

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment420
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00141128Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.PHASE2 COMPLETED 18 — — Dec 1, 2005Jun 1, 2006Jun 1, 20111 Denmark
NCT00138749An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.PHASE2 COMPLETED 402 — — Nov 1, 2004Aug 1, 2006Apr 7, 201195 United States, Canada
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Study Endpoints
Primary Endpoints
To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.
Secondary Endpoints
To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
SS-RBXDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female * Stress urinary incontinence Exclusion Criteria: * Bladder outflow obstruction * Neurological disease

Countries:DenmarkUnited StatesCanada
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