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Ilaprazole

Phase 2

Esophagitis | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment831

FDA Designations

No designations recorded

Clinical trial landscape

Ilaprazole · 1 trial · 1 indication

Phase 2 1
NCT00471094Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive EsophagitisEsophagitis
COMPLETED831 Analytics
PHASE2COMPLETED
Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
EsophagitisUnlock trial analytics

Study Endpoints

Primary Endpoints

The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
Week 4

Secondary Endpoints

The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.
Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ilaprazole 5 mg QDEXPERIMENTAL -
Ilaprazole 20 mg QDEXPERIMENTAL -
Ilaprazole 40 mg QDEXPERIMENTAL -
Lansoprazole 30 mg QDACTIVE_COMPARATOR -

Interventions

NameTypeDescription
IlaprazoleDRUGIlaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
LansoprazoleDRUGLansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites94

Inclusion Criteria: * Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: * Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condit...

Countries:United States
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Competitive Landscape -Eosinophilic Esophagitis 9 trials (matched to "Esophagitis")

Frequently asked questions about Ilaprazole

What is Ilaprazole used for?

Ilaprazole is an investigational small molecule being studied for the treatment of esophagitis, specifically erosive esophagitis. It is a gastrointestinal therapeutic agent under clinical development, though it is not yet approved and remains in clinical trials.

Who makes Ilaprazole?

Ilaprazole is being developed by Takeda Pharmaceutical Company Limited, a company listed on the stock exchange under the ticker TAK. The drug is currently in Phase 2 clinical development for the treatment of esophagitis.

What phase is Ilaprazole in?

Ilaprazole is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating esophagitis.

What clinical trials is Ilaprazole in?

Ilaprazole has one completed clinical trial, identified as NCT00471094. This Phase 2 study evaluated the safety and efficacy of Ilaprazole at doses of 5, 20, and 40 mg once daily compared to Lansoprazole 30 mg once daily for healing erosive esophagitis. The trial enrolled 831 participants in the United States.

Is Ilaprazole the same as any other drug?

Ilaprazole is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied as a potential treatment for esophagitis, but no alternative names have been established for this compound.