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Erosive EsophagitisPhase 3NCT02388737

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

A Phase 3 study testing Vonoprazan and Lansoprazole in people with Erosive Esophagitis, run by Takeda at 72 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

This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Erosive Esophagitis
What is being tested?
Vonoprazan and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
703 participants
Where
72 sitesin 4 countries
Study dates
1 Apr 2015to 31 Dec 2018
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

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • Has been confirmed on endoscopy to have had erosive esophagitis [Los Angeles (LA) classification grades A to D] within 84 days of Day 1.
  • If the participant is not rolled over from TAK-438_303 study, he/she has undergone an open-label Proton pump inhibitor (PPI) treatment (Lansoprazole 30 mg, once daily) of 4 or 8 weeks within the TAK-438_305 protocol.
  • Has been confirmed on endoscopy to have healing of erosive esophagitis. This endoscopy, if not part of the TAK-438_303 study, must have been within the last 14 days prior to randomization, otherwise the endoscopy must be repeated to confirm healing before randomization in the TAK-438_305 study.
  • Is aged 18 years old or older (or the local age of consent if that is older), male or female, at the time of signing an informed consent, and is being treated on an outpatient basis for erosive esophagitis, including those temporarily admitted for examination.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose of study medication.

Who cannot join

  • Has received any investigational compound (other than study TAK-438_303) within 84 days prior to screening phase.
  • Has received TAK-438 in a previous clinical study (other than study TAK-438_303) or as a therapeutic agent.
  • Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
  • Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease.
  • Has a history of hypersensitivity or allergies to TAK-438 or to proton pump inhibitors (PPIs) including any associated excipients.
Show all 20Show fewer
  • Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the start the screening phase.
  • Is required to take excluded medications.
  • If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  • Has participated in another clinical study (other than study TAK-438_303) within the past 30 days from Visit 1.
  • Has co-morbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures), a history of radiotherapy or cryotherapy for the esophagus; those with corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring or Barrett's esophagus).
  • Has a history of surgical procedures that may affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures excluding Schatzki's ring) or a history of gastric or duodenal surgery excluding endoscopic removal of benign polyps.
  • Developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Phase (Visit 1) (with the possible inclusion of those with gastric or duodenal erosion). Participants requiring non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin treatment along with the concomitant PPI therapy to prevent gastrointestinal (GI) bleeding should not be enrolled.
  • Has Zollinger-Ellison syndrome or gastric acid hypersecretion or a history of gastric acid hypersecretion.
  • Is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
  • Has a history of malignancy or was treated for malignancy within 5 years before the start of the Screening Phase (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 acquired immunodeficiency syndrome (AIDS) or hepatitis, 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-antigen or HCV-ribonucleic acid [RNA]-negative).
  • Laboratory tests performed on visit 1 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).

Trial locations and contacts

72 sites in 4 countries.

72 sites in 4 countries

China41 sites

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100020

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • The General Hospital of Peoples Armed Police Forces China

    Beijing, Beijing Municipality, 100039

  • Beijing Tongren Hospital, Capital Medical Univeristy

    Beijing, Beijing Municipality, 100370

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • PLA.The Military General Hospital of Beijing

    Beijing, 100853

  • Study site

    Beijing

  • No.2 Hospital Affiliated to Jilin University

    Changchun, Jilin, 130041

  • 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, 0

  • Fuzhou General Hospital of Nanjing Military Command

    Fuzhou, Fujian, 350100

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat- Sen University

    Guangzhou, Guangdong, 510655

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • 2nd Affiliated Hospital, Zhejiang Univ. School of Medicine

    Hangzhou, Zhejiang, 310009

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

    Hangzhou, Zhejiang, 310016

  • 1st Affiliated Hospital of Zhejiang University

    Hangzhou

  • China-Japan Union Hospital of Jilin University

    Jilin City, Jilin, 130033

  • Jilin central Hospital

    Jilin City, Jilin, 132011

  • The First Affiated Hospital of Kunming Medical College

    Kunming, Yun'nan, 650032

  • The First Affiliated Hospital of NanChang University

    Nanchang

  • Jiangsu Province People's Hospital

    Nanjing, Jiangsu, 210029

  • The Affiliated DrumTower Hospital of Nanjing University

    Nanjing, 210008

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

    Shanghai, Shanghai Municipality, 200025

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • TongJi Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Sixth Peoples Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200233

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000

  • Jilin Siping Central Hospital

    Siping, Jilin, 136000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • Study site

    Tianjing

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • Peoples Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Xiangtan Central Hospital

    Xiangtan, Hu'nan, 411100

  • Yangzhou 1st Hospital

    Yangzhou, Jiangsu, 225001

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui, 750004

Other trials in China

South Korea12 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Medical Center

    Daegu, Gyeongsangbuk-do, 41404

  • Yeungnam University Hospital

    Daegu, 42415

  • Wonkwang University School Of Medicine & Hospital

    Iksan-si, Jeollabuk-do, 54538

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, Gyeonggi-do, 03080

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital

    Seoul, 06591

Other trials in South Korea

Taiwan11 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • E-Da Hospital

    Kaohsiung City, 824

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 333

  • Chung Shan Medical University Hospital

    Taichung, 402

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 144

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan County, 333

Other trials in Taiwan

Malaysia8 sites

  • Hospital Sultana Bahiyah

    Alor Star, Kedah, 5460

  • Hospital Ampang

    Ampang, Selangor, 68000

  • Hospital Universiti Sains Malaysia

    Kelantan, Kelantan, 16150

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88586

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

Other trials in Malaysia

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis

This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

Read the detailed description

The drug being tested in this study is called vonoprazan. Vonoprazan is being tested as a maintenance treatment for people with healed erosive esophagitis (EE). This study will look at participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to Lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

The study will enroll approximately 693 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • TAK-438 10 mg
  • TAK-438 20 mg
  • Lansoprazole 15 mg

Participants with ongoing erosive esophagitis (EE) will receive lansoprazole 30 mg once daily for 4 or 8 weeks (the Healing phase) until healing of EE is confirmed by endoscopy performed at either Week -4 and/or Day 1 before eligible for randomization to maintenance phase. In Maintenance phase, participants with confirming EE healing will be asked to take 2 tablets and a capsule at the same time each morning after breakfast throughout the study. All participants will be asked to record daytime and nighttime (during sleep) subjective symptoms in a diary on a daily basis.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 8 months. Participants will make multiple visits to the clinic, and will be contacted by telephone 7-14 days after last dose of study drug for a follow-up assessment.

Being tested
Vonoprazan, Lansoprazole, Vonoprazan Placebo, Lansoprazole Placebo
Keywords
Drug therapy

What participants receive

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

  • VonoprazanDrug

    Also called TAK-438

    Vonoprazan tablets

  • LansoprazoleDrug

    Also called Prevacid

    Lansoprazole capsules or tablets

  • Vonoprazan PlaceboDrug

    Vonoprazan placebo-matching tablets

  • Lansoprazole PlaceboDrug

    Lansoprazole placebo-matching capsules

Study groups in NCT02388737
Study groupRoleWhat they receive
Vonoprazan 10 mgExperimentalLansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Receives: Drug: Vonoprazan; Drug: Lansoprazole; Drug: Vonoprazan Placebo; Drug: Lansoprazole Placebo
Vonoprazan 20 mgExperimentalLansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing
Receives: Drug: Vonoprazan; Drug: Lansoprazole; Drug: Vonoprazan Placebo; Drug: Lansoprazole Placebo
Lansoprazole 15 mgActive comparatorLansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Receives: Drug: Lansoprazole; Drug: Vonoprazan Placebo

What is being measured

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

  1. Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase

    Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles [LA] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: >/=1 mucosal breaks </=5 mm, none of which extends between the tops of the mucosal folds; Grade B: >/=1 mucosal breaks >5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve <75% of esophageal circumference; Grade D: mucosal breaks which involve >/=75% of esophageal circumference.

    Measured: 24 weeks

Secondary outcomes (8)

  1. Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase

    Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: >/=1 mucosal breaks </=5 mm, none of which extends between the tops of the mucosal folds; Grade B: >/=1 mucosal breaks >5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve <75% of esophageal circumference; Grade D: mucosal breaks which involve >/=75% of esophageal circumference.

    Measured: 12 weeks

  2. Number of Participants With Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.

    Measured: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

  3. Number of Participants With Abnormal Clinical Laboratory Findings

    Clinical laboratory safety tests included chemistry, hematology and urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter.

    Measured: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

  4. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.

    Measured: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

  5. Number of Participants With Abnormal Vital Sign Measurements

    The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury.

    Measured: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

  6. Change From Baseline in Serum Gastrin

    Measured: Baseline and Weeks 4, 12 and 24

  7. Change From Baseline in Serum Pepsinogen I

    Measured: Baseline and Weeks 4, 12 and 24

  8. Change From Baseline in Serum Pepsinogen II

    Measured: Baseline and Weeks 4, 12 and 24

Timeline

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

  1. First posted17 Mar 2015 (estimated)
  2. Study start1 Apr 2015
  3. Primary completion24 Dec 2018
  4. Study completion31 Dec 2018

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
703 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388737
Sponsor's protocol ID
TAK-438_305
Other IDs
U1111-1136-5706, CTR20150039
Status last verified
Feb 2020
First submitted
9 Mar 2015
Last updated
21 Feb 2020
Data monitoring committee
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

  • Xiao Y, Qian J, Zhang S, Dai N, Chun HJ, Chiu C, Chong CF, Funao N, Sakurai Y, Eisner JD, Xie L, Chen M. Vonoprazan 10 mg or 20 mg vs. lansoprazole 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis: A randomized controlled trial. Chin Med J (Engl). 2024 Apr 20;137(8):962-971. doi: 10.1097/CM9.0000000000003068. Epub 2024 Mar 29.

    PubMed 38654422

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vonoprazan and Lansoprazole in people with Erosive Esophagitis, run by Takeda at 72 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 7 inclusion and 20 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 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in China, South Korea, Taiwan, Malaysia. 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 21 Feb 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 Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase (time frame: 24 weeks). 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 NCT02388737, 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 21 Feb 2020.

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