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Protocol NumberTAK-438_302
NCT Number(ClinicalTrials.gov Identfier)NCT03050307

2017-03-01 - 2020-06-30

Phase III

Recruiting5

ICD-10K25.9

Gastric ulcer, unspecified as acute or chronic, without hemorrhage or perforation

ICD-10K25

Gastric ulcer

A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20mg Compared to Lansoprazole 30mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Gastric Ulcer Subjects With or Without Helicobacter Pylori Infection

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Takeda Development Center Asia Pte. Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 謝財源 Digestive System Department
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jiing-Chyuan Luo Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ken-Sheng Cheng Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ken-Sheng Cheng 未分科
China Medical University Hospital-Taipei

Taiwan National PI

鄭庚申

Co-Principal Investigator

Audit

None

Principal Investigator Cheng-Tang Chiu Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Taiwan National PI

邱正堂

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Recruiting

Audit

None

Principal Investigator Ming-Shiang Wu Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Gastric Ulcer

Objectives

Primary Objective: To demonstrate the noninferior efficacy of TAK-438 versus lansoprazole in the treatment of subjects with gastric ulcer. Secondary Objectives: To demonstrate the noninferiority of H pylori (HP) eradication with TAK-438 versus lansoprazole. To compare the safety of TAK-438 versus lansoprazole in subjects with gastric ulcer.

Test Drug

TAK-438

Active Ingredient

vonoprazan

Dosage Form

Tablets

Dosage

20

Endpoints

1. Primary Endpoints:
 The primary endpoint for this study is the percentage of subjects with endoscopically confirmed
healing* of gastric ulcer(s) at Week 4 or 8*.
*Rate of endoscopic healing: defined as the proportion of subjects in whom the disappearance of all
white coats associated with gastric ulcers has been endoscopically confirmed.
2. Secondary Endpoints:
 Percentage of HP+ subjects with successful H pylori eradication after 4 or 8 weeks of treatment, as
determined by 13C-UBT at F-2.
 Percentage of subjects with endoscopically confirmed healing of gastric ulcer at Week 4.
 Percentage of subjects with posttreatment resolution of gastrointestinal symptoms associated with
gastric ulcer (epigastric pain [postprandial, fasting, nocturnal], abdominal bloating, nausea/vomiting,
heartburn, lack of appetite) at Weeks 2 through 8.
3. Additional Endpoints:
Other efficacy endpoints include:
 Quality of Life measurements - Euro Quality of Life-5D-5L (EQ-5D-5L).
 Percentage of subjects with endoscopically confirmed healing of gastric ulcer at either Week 4 or Week
8 based on their Baseline H pylori status.
 Percentage of subjects with endoscopically confirmed healing of gastric ulcer at Week 4 based on their
Baseline H pylori status.
 Percentage of subjects with H pylori infection at Baseline who achieve endoscopically confirmed
healing of gastric ulcer either at Week 4 or Week 8 based on their H pylori status at follow-up visit F-2.
 Percentage of subjects with H pylori infection at Baseline who achieve endoscopically confirmed
healing of gastric ulcer at Week 4 based on their H pylori status at follow-up visit F-2.
The safety endpoints of this study include adverse events (AEs), laboratory test values, electrocardiogram
(ECG), vital signs, serum gastrin-17 and pepsinogen I/II values (total and ratio).

Inclution Criteria

Main Criteria for Inclusion:
Subjects with endoscopic evidence of one or more active gastric ulcer(s) (ie, mucosal defects with white coating
[including cases associated with blood coagula]) measuring 5 mm or larger in longest diameter within 14 days
prior to randomization, who have provided (or when applicable their legally acceptable representative has
provided) informed consent, who are capable of understanding and complying with the study procedures and
who agree to use appropriate contraception.

Exclusion Criteria

Main Criteria for Exclusion:
Subjects who have hypersensitivity to TAK-438, or related compounds or to proton pump inhibitors (PPIs),
clarithromycin, amoxicillin, bismuth or lansoprazole; or who have a significant history of CNS, cardiovascular,
pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease; or subjects
with a liver function test > upper limit of normal; or who have any significant results from physical
examinations, or clinical laboratory results as deemed by the investigator. Subjects that have received HP
eradication therapy 30 days prior to visit 2 or endoscopic therapy within 30 days prior to visit 1 or also have
active duodenal ulcer(s) are also excluded.

The Estimated Number of Participants

  • Taiwan

    75 participants

  • Global

    830 participants

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