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Duodenal UlcerPhase 3NCT03050359

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection

A Phase 3 study testing TAK-438, Lansoprazole and Bismuth-Containing Quadruple Therapy in people with Duodenal Ulcer, run by Takeda at 81 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Duodenal Ulcer
What is being tested?
TAK-438, Lansoprazole and Bismuth-Containing Quadruple Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
533 participants
Where
81 sitesin 4 countries
Study dates
5 Apr 2017to 19 Jul 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Has endoscopic evidence of active duodenal ulcer(s) (i.e., mucosal defects with white coating [including cases associated with blood coagulation as long as there is no active bleeding]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.

Who cannot join

  • Has received TAK-438 in a previous clinical study or as a therapeutic agent.
  • Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  • Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.
  • Has a diagnosis of duodenal malignancy or a duodenal ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.
  • Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.
  • Has a linear ulcer (including a linear ulcer scar) that has been confirmed as evident by endoscopy within 14 days prior to randomization.
Show all 18Show fewer
  • Has active postoperative (eg, endoscopic mucosal resection / endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.
  • Has gastric ulcer that has been confirmed by endoscopy within 14 days prior to randomization.
  • Has ulcers for which medical therapy alone is not indicated (eg, perforation, pyloric stenosis, duodenal stenosis, major bleeding).
  • Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (eg, endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.
  • Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
  • Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (eg, abdominal surgery, vagotomy or craniotomy).
  • Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
  • Has a known acquired immunodeficiency syndrome (AIDS) or hepatitis infection, including hepatitis virus carriers (hepatitis B surface-antigen [HBsAg] - or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-viral load-RNA-negative).
  • Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant:
  • Creatinine levels: >2 mg/dL (>177 μmol/L).
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: > upper limit of normal (ULN).
  • Has hypersensitivity to TAK-438, proton pump inhibitors (PPIs), bismuth, clarithromycin, or amoxicillin. Skin testing may be performed according to local standard practice (for HP+ participants only).

Trial locations and contacts

81 sites in 4 countries.

81 sites in 4 countries

China53 sites

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100020

  • The General Hospital of People's Armed Police Forces China

    Beijing, Beijing Municipality, 100039

  • The Central Hospital of China Aerospace Corporation

    Beijing, Beijing Municipality, 100049

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Peking University First Hospital

    Beijing,P.R., Beijing Municipality, 100034

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • Jilin 4th People'S hospital

    Changchun, Jilin, 130012

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

  • The 2nd Xiangya Hospital Central South University

    Changsha, Hu'nan, 410011

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • Chenzhou No.1 People's Hospital

    Chenzhou, Hu'nan, 432000

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 40010

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

    Fuzhou, Fujian, 350025

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • Haikou People's Hospital

    Haikou, Hainan, 570208

  • 1st Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310013

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310016

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230024

  • Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

    Huangpu Qu, Shanghai Municipality, 200020

  • Jilin central Hospital

    Jilin City, Jilin, 132011

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434020

  • The First Affiliated Hospital of Kunming Medical College

    Kunming, Yun'nan, 650032

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006

  • Jiangxi Nanchang 3rd Hospital

    Nanchang, Jiangxi, 330009

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210012

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality, 200442

  • General Hospital of Shenyang Military Region

    Shenyang, Liaoning, 110016

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000

  • Shiyan Taihe Hospital

    Shiyan, Hebei, 442000

  • Jilin Siping Central Hospital

    Siping, Jilin, 136000

  • Tianjin Medical University Affiliated General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The Second Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325027

  • Union Hospital of Tongji Medical College of Huazhong Science and Techology University

    Wuhan, Hubei, 420104

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Wuhan General Hospital of Guangzhou Military

    Wuhan, Hubei, 430070

  • Yijishan hospital of Wan nan Medical college

    Wuhu, Anhui, 241001

  • Wuxi 4th People's Hospital

    Wuxi, Jiangsu, 214062

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 241023

  • The 2nd Hospital of Xi An Jiaotong University

    Xi'an, Shan'xi, 710004

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • People's Hospital of Qinghai Province

    Xining, Qinghai, 810007

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui, 750004

  • Changsha Central Hospital

    Yuhua, Hu'nan, 410018

  • Zhangzhou Hospital

    Zhangzhou, Fujian, 363000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

South Korea17 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

  • The Catholic University of Korea, Bucheon St. Mary s Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • Hanyang Univerisy Guri Hospital

    Guri-si, Gyeonggi-do, 11923

  • Chonnam National University Hospital

    Gwangju, 61469

  • Wonkwang University Hospital

    Iksan-si, Jeollabuk-do, 54538

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 21431

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Philippines6 sites

  • Cebu Doctors University Hospital

    Cebu City, 6000

  • St. Luke's Medical Center Global City

    City of Taguig, 1634

  • De La Salle University Medical Center

    Dasmarinas City, Cavite, 4114

  • Davao Doctors Hospital

    Davao City, 8000

  • West Visayas State University Medical Center

    Iloilo City, 5000

  • Philippine General Hospital

    Manila, 1000

Other trials in Philippines

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan County, 333

Other trials in Taiwan

About this study

Official title: 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

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.

Read the detailed description

The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have duodenal ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at duodenal ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole. The study will enroll approximately 530 patients.

Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • TAK-438 20 mg
  • Lansoprazole 30 mg

HP+ participants will be asked to take a TAK- 438 tablet and a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet and a lansoprazole capsule once daily for up to 4 weeks. HP negative (HP-) participants will be asked to take a TAK-438 tablet and a lansoprazole capsule once daily for up to 6 weeks.

This multi-center trial will be conducted China, Korea and Taiwan. The overall time to participate in this study is up to 10 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.

Conditions
Duodenal Ulcer
Being tested
TAK-438, Lansoprazole, TAK-438 Placebo, Lansoprazole Placebo, Bismuth-Containing Quadruple Therapy
Keywords
Drug therapy, Gastrointestinal Diseases, Digestive System Diseases, Lansoprazole, Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
Medical subject headings
Duodenal Ulcer, Gastrointestinal Diseases, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-438Drug

    Also called Vonoprazan

    TAK-438 tablets

  • LansoprazoleDrug

    Also called Prevacid

    Lansoprazole capsules

  • TAK-438 PlaceboDrug

    TAK-438 placebo-matching tablets.

  • Lansoprazole PlaceboDrug

    Lansoprazole placebo-matching capsules

  • Bismuth-Containing Quadruple TherapyDrug

    1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).

Study groups in NCT03050359
Study groupRoleWhat they receive
TAK-438 20 mgExperimentalH. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
Receives: Drug: TAK-438; Drug: Lansoprazole Placebo; Drug: Bismuth-Containing Quadruple Therapy
Lansoprazole 30 mgExperimentalH. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
Receives: Drug: Lansoprazole; Drug: TAK-438 Placebo; Drug: Bismuth-Containing Quadruple Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers

    Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.

    Measured: Week 4 or Week 6

Secondary outcomes (3)

  1. Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment

    HP infection status was determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.

    Measured: 4 weeks post treatment (Up to 10 weeks)

  2. Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4

    Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.

    Measured: Week 4

  3. Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6

    The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3.

    Measured: Week 2 up to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study start5 Apr 2017
  3. Primary completion19 Mar 2019
  4. Study completion19 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03050359
Sponsor's protocol ID
TAK-438_304
Other IDs
U1111-1139-0293, CTR20170104
Status last verified
May 2020
First submitted
8 Feb 2017
Last updated
12 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Publications

  • Hou X, Wang J, Du Q, Tian D, Hu N, Liu D, Zhou F, Xie L, Gu L, Kudou K, Zhang S. Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials. Biol Pharm Bull. 2024;47(8):1405-1414. doi: 10.1248/bpb.b24-00011.

    PubMed 39085080

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-438, Lansoprazole and Bismuth-Containing Quadruple Therapy in people with Duodenal Ulcer, run by Takeda at 81 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in China, South Korea, Philippines, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers (time frame: Week 4 or Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.

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