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alosetron

Phase 3

Irritable Colon | Small molecule | Gastrointestinal |GSK plc|Last Updated: Apr 16, 2015

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 Trials2
Total Enrollment1,402
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00067457Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional TherapyPHASE3 COMPLETED 700 — — Jun 1, 2003Dec 1, 2005Apr 16, 2015191 United States, Australia
NCT00067561Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional TherapyPHASE3 COMPLETED 702 — — Jun 1, 2003Jan 1, 2005Apr 16, 2015178 United States, Australia
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Study Endpoints
Primary Endpoints
Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.
12 Weeks
Secondary Endpoints
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.
12 Weeks
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
alosetronDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites191

Inclusion Criteria: * Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS). * Failed conventional therapy. * Willing to make daily calls on a touch-tone telephone. Exclusion criteria: * History of or current chronic or severe constipation. * Bloody diarrhea, abdominal pain wi...

Countries:United StatesAustralia
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