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Itopride HCI

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Abbott Laboratories|Last Updated: Jun 18, 2013

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment268
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01027260Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant ConstipationPHASE2 COMPLETED 268 — — Jun 1, 2008Sep 1, 2010Jun 18, 20134 Pakistan
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Study Endpoints
Primary Endpoints
Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
2 weeks and 4 weeks after the start of the treatment
Secondary Endpoints
Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).
2 weeks and 4 weeks after the start of the treatment
Safety based on the laboratory tests before and at the end of the treatment.
4 weeks during the treatment period and 4 weeks following post- therapy period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Itopride 50 mgACTIVE_COMPARATOR -
Itopride 100 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Itopride HCI 50 mgDRUGVariable dosing
Itopride HCI 100 mgDRUGVariable dosing
PlaceboDRUGVariable dosing
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female patient fulfilling the Rome III criteria for IBS-C 2. Signed informed consent at screening visit Exclusion Criteria: 1. Patients having significant diarrhea at least 25% of the time during the past 3 months 2. Patients having alarm symptoms or signs 3. Chroni...

Countries:Pakistan
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Competitive Landscape -Irritable Bowel Syndrome 13 trials
CompanyTickerTrialsLead PhaseDrugs
Ardelyx, Inc.ARDX4PHASE3Tenapanor
AbbVie, Inc.ABBV2PHASE3Eluxadoline
Disc Medicine, Inc.IRON1PHASE2DISC-0974
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2 — Undisclosed
Johnson & JohnsonJNJ1 — Anti TNF therapy including infliximab, No Biologics
Cooper Companies, Inc.COO1NAUndisclosed
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