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Esophagitis PepticVIEWNCT04501627

A Study on Vonoprazan in the Real-world Clinical Practice in China

An observational study of Esophagitis Peptic, run by Takeda at 40 sites in China.

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 this study is to evaluate the safety of Vonoprazan by assessing all adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine clinical settings in China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagitis Peptic
How many people
3,000 participants
Where
40 sitesChina
Study dates
24 Dec 2020to 27 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Chinese participants who are prescribed with vonoprazan treatment in real-world clinical practice will be observed prospectively.

Who may be able to join

  • Must be undergoing treatment with Vonoprazan.
  • Must be at least 18 years old.
  • Provide signed informed consent indicating that they (or a legally acceptable representative) have been informed of all pertinent aspects of the study and are willing to participate.

Who cannot join

  • Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study).
  • Are contraindicated for Vonoprazan according to Product Package Insert.
  • With a known hepatic function impairment, including jaundice.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 000000

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changshu No.2 People's Hospital

    Changshu, Jiangsu, 215500

  • Chengdu Third People's Hospital

    Chengdu, Sichuan, 610031

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang, 310000

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Heilongjiang Provincial Hospital (Nanshang)

    Harbin, Heilongjiang, 150036

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Medical School of Ningbo University

    Ningbo, Zhejiang, 315105

  • Qilu Hospital of Shandong University (Qingdao)

    Qingdao, Shandong, 266035

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

    Shanghai, Shanghai Municipality, 200092

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    Shenzhen, Guangdong, 518052

  • General Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300052

  • Weifang Peoples Hospital

    Weifang, Shandong, 261041

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang, 325000

  • The Second Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325027

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • Yantai Affiliated Hospital of Binzhou Medical College

    Yantai, Shandong, 264100

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    Yiwu, Zhejiang, 32200

  • Yongchuan Hospital of Chongqing Medical University

    Yongchuan, Chongqing Municipality, 402160

  • Henan Provincial Peoples Hospital

    Zhengzhou, Henan, 450003

  • Zhuhai People's Hospital

    Zhuhai, Guangdong, 519050

Other trials in China

About this study

Official title: A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China

The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine clinical settings in China.

Read the detailed description

This is a prospective, non-interventional study in Chinese participants with RE who are receiving or will receive the standard treatment of vonoprazan. This study will assess the safety and effectiveness of vonoprazan in the real-world clinical practice.

The study will enroll approximately 3000 participants. The data will be collected through participants' medical records, self-reported questionnaires, and recorded information on symptom via diaries. All the participants will be assigned to a single observational cohort:

  • Participants with RE

The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be followed up for additional 2 weeks after the standard treatment. The overall duration of the study will be approximately 10 weeks.

Keywords
Drug Therapy
Medical subject headings
Esophagitis, Peptic

What participants receive

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

Study groups in NCT04501627
Study groupRoleWhat they receive
Participants with REParticipants diagnosed with RE who have received 20 milligram (mg) of vonoprazan in routine clinical practice, will be observed prospectively. Data will be collected from participants' medical records, self-reported questionnaires and recorded information on symptom via diaries.

What is being measured

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

  1. Percentage of Participants Reporting one or More AEs

    Measured: Up to Week 10

  2. Percentage of Participants Reporting one or More SAEs

    Measured: Up to Week 10

  3. Percentage of Participants Reporting one or More ADRs

    ADRs refers to AE related to administered drug.

    Measured: Up to Week 10

Secondary outcomes (8)

  1. Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment

    Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break less than [<] 5 millimeter [mm]), Grade B (Mucosal break greater than or equal to [>=] 5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75 percent [%] of the esophageal circumference).

    Measured: Baseline up to Week 4

  2. Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment

    Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break >=5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75% of the esophageal circumference).

    Measured: Baseline up to Week 8

  3. Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms

    The severity of participants' GERD symptoms based on the investigator's assessment among all participants will be evaluated at Baseline and Week 4. GERD symptoms will be assessed on a 5-point scale, wherein 1= no symptom, 2= mild, 3= moderate, 4= severe and 5= very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP). The participants without any GERD typical symptoms will be analyzed.

    Measured: Baseline and Week 4

  4. Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment

    The complete relief of heartburn symptom is defined as no such symptom occurred on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete heartburn symptom relief) divided by (the total number of participants) *100%.

    Measured: Baseline up to Week 1

  5. Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment

    The complete relief of night time heartburn symptoms is defined as no such symptom occurred on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time heartburn symptom relief) divided by (the total number of participants) *100%.

    Measured: Baseline up to Week 1

  6. Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment

    The complete relief of acid regurgitation symptom is defined as no symptoms of acid regurgitation occurring on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete acid regurgitation symptom relief) divided by (the total number of participants) *100%.

    Measured: Baseline up to Week 1

  7. Percentage of Participants With Night Time Acid Regurgitation Symptom at Baseline Achieving Complete Night Time Acid Regurgitation Symptom Relief During the First Week of Treatment

    The complete relief of acid regurgitation symptoms durng night time is defined as no symptoms of acid regurgitation occurring on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time acid regurgitation symptom relief) divided by (the total number of participants) *100%.

    Measured: Baseline up to Week 1

  8. Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4

    GerdQ is a self-completed participant questionnaire that is used to assess whether the following symptoms of RE are improved under treatment: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GerdQ score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GerdQ >=8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points= 0% likelihood of GERD; 3 to 7 points= 50% likelihood of GERD; 8 to 10 points= 79% likelihood of GERD; 11 to 18 points= 89% likelihood of GERD.

    Measured: Baseline up to Week 4

Timeline

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

  1. First posted6 Aug 2020
  2. Study start24 Dec 2020
  3. Primary completion27 Jun 2023
  4. Study completion27 Jun 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501627
Sponsor's protocol ID
Vonoprazan-4007
Acronym
VIEW
Status last verified
Oct 2023
First submitted
4 Aug 2020
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Xiao YL, Yang H, Lu YX, Yang L, Zhang GX, Ye GL, Song Q, Xie L, Chen MH. Real-World Safety of Vonoprazan in Patients and Symptom Outcomes in Patients With Reflux Esophagitis in China: A Prospective, Non-Interventional Study (VIEW). J Dig Dis. 2026 Mar-Apr;27(3-4):150-159. doi: 10.1111/1751-2980.70051. Epub 2026 May 21.

    PubMed 42168696

Questions about this trial

What is this clinical trial studying?

An observational study of Esophagitis Peptic, run by Takeda at 40 sites in China.

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 3 inclusion and 3 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Reporting one or More AEs (time frame: Up to Week 10). The study lists 3 primary outcomes in all. 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 NCT04501627, 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 25 Oct 2023.

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