Recent Updates
Recently added Catalysts

Gefarnate

Phase 3

Stomach Ulcer | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Feb 3, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment366
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00787254Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory DrugsPHASE3 COMPLETED 366 — — Apr 1, 2007May 1, 2009Feb 3, 201268 Japan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
24 Months

The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.

Secondary Endpoints
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Baseline and Month 12.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lansoprazole 15 mg QDEXPERIMENTAL -
Gefarnate 50 mg BIDACTIVE_COMPARATOR -
Interventions
NameTypeDescription
LansoprazoleDRUGLansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
GefarnateDRUGGefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started. * The patient was confirmed to have a history of gastric ...

Countries:Japan
Unlock Eligibility Criteria