台灣臨床試驗主持人資料庫|TPIDB

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberTAK-438_304

NCT Number(ClinicalTrials.gov Identfier)NCT03050359

2017-03-01 - 2019-09-30

Phase III

Terminated5

ICD-10K26.4

Chronic or unspecified duodenal ulcer with hemorrhage

ICD-10K26

Duodenal ulcer

A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically confirmed Duodenal 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

黃天祐 Digestive System Department
林榮鈞 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jiing-Chyuan Luo Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

陳炳憲 Digestive System Department
李癸汌 Digestive System Department
王彥博 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ken-Sheng Cheng Digestive System Department

China Medical University Hospital

Co-Principal Investigator

余承儒 Digestive System Department
Jen-Wei Chou Digestive System Department
Hung-Wei Wang Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

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

林淳榮 Division of General Internal Medicine
陳聰興 Division of General Internal Medicine
Puo-Hsien Le Division of General Internal Medicine
許振銘 Division of General Internal Medicine
林蔚然 Division of General Internal Medicine
Cheng-Yu Lin Division of General Internal Medicine
何玉彬 Division of General Internal Medicine
Chia-Jung Kuo Division of General Internal Medicine
Ming-Yao Su Division of General Internal Medicine
林偉彬 Division of General Internal Medicine
Puo-Hsien Le Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

1 Terminated

Audit

None

Principal Investigator Ming-Shiang Wu Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

JYH-MING LIOU Digestive System Department
曾屏輝 Digestive System Department
陳介章 Digestive System Department
YI-CHIA LEE Digestive System Department
HAN-MO CHIU Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Duodenal Ulcer

Objectives

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

Test Drug

TAK-438

Active Ingredient

vonoprazan

Dosage Form

Tablets

Dosage

Endpoints

1. Primary Endpoint:
 The primary endpoint for this study is the percentage of subjects with endoscopically confirmed healing* of
duodenal ulcer(s) at Week 4 or 6*.
*Rate of endoscopic healing: defined as the proportion of subjects in whom the disappearance of all white
coats associated with duodenal ulcers has been endoscopically confirmed.
2. Secondary Endpoints:
 Percentage of HP+ subjects with successful H pylori eradication after 4 or 6 weeks of treatment, as
determined by 13C UBT at F-2.
 Percentage of subjects with endoscopic healing of duodenal ulcer at Week 4.
 Percentage of subjects with posttreatment resolution of gastrointestinal symptoms associated with duodenal
ulcer (epigastric pain [postprandial, fasting, nocturnal], abdominal bloating, nausea/vomiting, heartburn,
lack of appetite) at Weeks 2 through 6.

Inclution Criteria

Main Criteria for Inclusion:
Subjects with endoscopic evidence of one or more active duodenal 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 gastric ulcer(s) are also excluded.

The Estimated Number of Participants

Taiwan

75 participants
Global

530 participants