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PD-217,014

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Jun 17, 2008

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 Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00139672A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.PHASE2 COMPLETED 330Jan 1, 2004Feb 1, 2005Jun 17, 2008 -
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Study Endpoints
Primary Endpoints
Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks).
Secondary Endpoints
Assess the effect of PD-217,014 on the patient's global assessment of IBS symptoms, stool frequency & consistency and on abdominal bloating (change from baseline to week 4).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
PD-217,014DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males and females having Irritable bowel syndrome as defined by the Rome II criteria. * Patients must have had normal examination of colon anatomy within the last 5 years Exclusion Criteria: * Patient with an organic gastrointestinal disease. * Patients with poor renal funct...

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