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DETROL LA

Phase 1

Overactive Bladder | Small molecule | Nephrology |GSK plc|Last Updated: Oct 26, 2010

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 Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00553657The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive BladderPHASE1 COMPLETED 55 — — Aug 1, 2007Jan 1, 2008Oct 26, 20101 Australia
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Study Endpoints
Primary Endpoints
Variability of change from baseline in mean volume per void measured on 3 consecutive days.
3 consecutive days
Secondary Endpoints
Mean change from baseline in volume voided per void. Percent and actual change from baseline in maximum volume voided, number of micturitions, number of incontinence episodes, number of urgency episodes, and time to first void on 3 consecutive days.
3 consecutive days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
DETROL LA (drug)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must rep...

Countries:Australia
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