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Gefarnate

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment366

FDA Designations

No designations recorded

Clinical trial landscape

Gefarnate · 1 trial · 2 indications

Phase 3 1
NCT00787254Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory DrugsStomach Ulcer
COMPLETED366 Analytics
PHASE3COMPLETED
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
Stomach Ulcer
NCT00787254366
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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.
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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.
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Eligibility Criteria

Age Range20 Years to 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
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Frequently asked questions about Gefarnate

What is Gefarnate used for?

Gefarnate is a small molecule being developed for the treatment of stomach ulcer. It is in Phase 3 clinical development. Gefarnate is being studied in patients with gastric and duodenal ulcers, particularly those taking nonsteroidal anti-inflammatory drugs.

Who makes Gefarnate?

Gefarnate is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 3 clinical development for the treatment of stomach ulcer.

What phase is Gefarnate in?

Gefarnate is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of stomach ulcer. The drug has completed one Phase 3 clinical trial and is not yet approved.

What clinical trials is Gefarnate in?

Gefarnate has been studied in one completed Phase 3 clinical trial, identified as NCT00787254. This trial evaluated the efficacy and safety of lansoprazole on gastric and duodenal ulcers in patients taking nonsteroidal anti-inflammatory drugs. The trial enrolled 366 participants in Japan.

Is Gefarnate FDA approved?

Gefarnate is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of stomach ulcer. The drug has completed one Phase 3 trial but has not yet received regulatory approval.