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Erosive EsophagitisPhase 3NCT02388724

Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis

A Phase 3 study testing Vonoprazan and Lansoprazole in people with Erosive Esophagitis, run by Takeda at 64 sites in 4 countries.

Completed

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

Official record
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Trial summary

The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8. 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
481 participants
Where
64 sitesin 4 countries
Study dates
24 Mar 2015to 27 Jul 2017
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 in an endoscopy to have erosive esophagitis, ie, the Los Angeles (LA) classification grades A to D within 7 days of the start of the Day 1 (Visit 2).
  • Note: The recruitment goal is to ensure that those with LA classification grade C/D will account for more than 30% of all participants enrolled (144/480), with no further recruitment of those with grade A/B considered when they account for more than 70% (336/480) of all participants.
  • 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 admitted temporarily 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.

Who cannot join

  • Has received any investigational compound within 84 days prior to the start of the Observation phase.
  • Has received TAK-438 in a previous clinical study or as a therapeutic agent.
  • Is an immediate family member, study site employee, or is in a dependant 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 serious central nerve system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease.
  • Has a history of hypersensitivity or allergies to TAK-438 (including its excipients*) or to proton pump inhibitors (PPIs).
Show all 22Show fewer
  • D-mannitol, crystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, yellow iron sesquioxide and iron sesquioxide.
  • Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Observation Phase (Visit 1).
  • 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 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 Observation Phase (Visit 1) (with the possible inclusion of those with gastric or duodenal erosion).
  • 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 Observation 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) positive, 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 at the start of the Early Observation Phase (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).
  • Is active in the Screening Period after the closure of enrollment identified by the Sponsor or the number of participants randomized with LA classification A/B or C/D have reached the required sample size.

Trial locations and contacts

64 sites in 4 countries.

64 sites in 4 countries

China32 sites

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100020

  • China-Japan Friendship hospital

    Beijing, Beijing Municipality, 100029

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Beijing Tongren Hospital, Capital Medical Univeristy

    Beijing, Beijing Municipality, 100370

  • PLA.The Military General Hospital of Beijing

    Beijing, Beijing Municipality, 100700

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • 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 First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 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

  • 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

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • Study site

    Tianjin

  • 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

  • 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

Taiwan12 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

  • Cheng Ching General Hospital-Chung Kang Branch

    Taichung, 407

  • 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, 114

  • 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 Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis

The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.

Read the detailed description

The drug being tested in this study is called vonoprazan. Vonoprazan is being tested to treat people who have erosive esophagitis. This study will look at mucosal healing of people who take vonoprazan versus lansoprazole.

This study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Vonoprazan 20 mg
  • Lansoprazole 30 mg

All participants will be asked to take one tablet and one capsule at the same time each day 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-center trial will be conducted worldwide. The overall time to participate in this study is up to 11 weeks. 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

  • Vonoprazan PlaceboDrug

    Vonoprazan placebo-matching tablets

  • Lansoprazole PlaceboDrug

    Lansoprazole placebo-matching capsules

Study groups in NCT02388724
Study groupRoleWhat they receive
Vonoprazan 20 mgExperimentalVonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
Receives: Drug: Vonoprazan; Drug: Lansoprazole Placebo
Lansoprazole 30 mgActive comparatorLansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
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 Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase

    Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.

    Measured: 8 weeks

Secondary outcomes (8)

  1. Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment

    Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.

    Measured: Week 2 and Week 4

  2. Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)

    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: On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks)

  3. Number of Participants With Markedly 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 10 weeks)

  4. Number of Participants With Markedly 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 10 weeks)

  5. Number of Participants With Markedly Abnormal Vital Sign Measurements

    Number of participants with any markedly abnormal vital signs measurements is reported. Vital signs included body temperature (oral, tympanic, or infra-axillary measurement), sitting blood pressure (5 minutes), and pulse. °C = degrees Celsius, mmHg = millimeters of mercury, bpm = beats per minute.

    Measured: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)

  6. Change From Baseline in Serum Gastrin

    The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline.

    Measured: Baseline and Weeks 2, 4, and 8

  7. Change From Baseline in Serum Pepsinogen I

    The change between the serum pepsinogen I values collected at Weeks 2, 4, and 8 relative to baseline.

    Measured: Baseline and Weeks 2, 4, and 8

  8. Change From Baseline in Serum Pepsinogen II

    The change between the serum pepsinogen II values collected at Weeks 2, 4, and 8 relative to baseline.

    Measured: Baseline and Weeks 2, 4, and 8

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 start24 Mar 2015
  3. Primary completion27 Jul 2017
  4. Study completion27 Jul 2017

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
481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388724
Sponsor's protocol ID
TAK-438_303
Other IDs
U1111-1138-4788, CTR20150040
Status last verified
Feb 2019
First submitted
9 Mar 2015
Last updated
3 Jun 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xiao Y, Zhang S, Dai N, Fei G, Goh KL, Chun HJ, Sheu BS, Chong CF, Funao N, Zhou W, Chen M. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut. 2020 Feb;69(2):224-230. doi: 10.1136/gutjnl-2019-318365. Epub 2019 Aug 13.

    PubMed 31409606

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 64 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 6 inclusion and 22 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 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 3 Jun 2019). 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 Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase (time frame: 8 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 NCT02388724, 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 3 Jun 2019.

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