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Itopride

Phase 2

Functional Dyspepsia | Small molecule | Other |Abbott Laboratories|Last Updated: May 4, 2006

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 Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00272103Itopride in Functional Dyspepsia:a Dose Finding StudyPHASE2 COMPLETED 500 — — Dec 1, 2000Jan 1, 2002May 4, 20061 Germany
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Study Endpoints
Primary Endpoints
After 8 weeks of treatment:
Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire)
Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)
Improvement of pain and/or fullness by at least one grade on a 5-grade scale.
Secondary Endpoints
Safety parameters
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Itopride (drug)DRUG -
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Eligibility Criteria
Age Range18 Years — 95 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Diagnosis of functional dyspepsia (Rome criteria) - Exclusion Criteria: structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture \-

Countries:Germany
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