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GW427353

Phase 2

Irritable Bowel Syndrome (IBS) | Small molecule | Gastrointestinal |GSK plc|Last Updated: May 18, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00394186A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)PHASE2 COMPLETED 100Aug 1, 2006 -May 18, 200919 Australia, France +1
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Study Endpoints
Primary Endpoints
completion of questionnaires by the subject, determining the average adequate relief rate
during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
Secondary Endpoints
Blood levels of GW427353
Week 1, 13
Questionnaire
Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
each visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
GW427353DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: \- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be \> 1.5 (0= no pain, 4 = very severe pain) Exclusion Criteria: * Subjects not meeting the Rome II criteria for the diagnosis of IBS * Subjects with no stool for 7 days during the screen

Countries:AustraliaFranceGermany
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