UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055462 |
|---|---|
| Receipt number | R000062608 |
| Scientific Title | Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/07/07 15:30:15 |
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Basic information
Public title
Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study
Acronym
Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study
Scientific Title
Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study
Scientific Title:Acronym
Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease (mild)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify factors associated with the recurrence of mild reflux esophagitis after 4 or 8 weeks of initial treatment with vonoprazan 20 mg/day.
Basic objectives2
Others
Basic objectives -Others
Gastroesophageal reflux disease symptom activity will be assessed using the GerdQ questionnaire before initial treatment, immediately after the completion of initial treatment, two weeks after treatment is discontinued, and four weeks after treatment is discontinued. Serum gastrin levels will also be measured on the day initial treatment is discontinued. In addition, the patient's gender, age, height, weight, smoking status, alcohol consumption, H. pylori infection status, medical history, and endoscopic examination findings at the first consultation will be evaluated to identify factors associated with the recurrence of gastroesophageal reflux disease.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors associated with symptom recurrence 2 weeks after discontinuing vonoprazan
Key secondary outcomes
Factors associated with symptom recurrence 4 weeks after discontinuation of vonoprazan
Factors associated with symptom recurrence 2 or 4 weeks after discontinuation of vonoprazan
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are adult patients who have been diagnosed with mild reflux esophagitis (Los Angeles Classification Grade A or B) by endoscopy before starting vonoprazan, and who have shown symptomatic cure by initial administration of 20 mg/day vonoprazan for 4 weeks, or for an additional 8 weeks if symptoms persist, following health insurance medical care in Japan. The therapeutic effect will be assessed using the GerdQ questionnaire, and symptoms will be cured if the score for questions 1, 2, 5, and 6 is 1 or less.
Key exclusion criteria
Patients with any of the following conditions will be excluded.
1) Severe reflux esophagitis
2) Non-erosive reflux esophagitis
3) Gastroduodenal ulcer
4) Post-surgery of the upper gastrointestinal tract
5) Use of acid secretion inhibitors (H2 blockers, PPIs, P-CABs) within the past 3 months
6) Use of medications that affect reflux esophagitis or heartburn (analgesics such as Rikkunshito, mosapride citrate, acotiamide, antipsychotics, and NSAIDs)
7) Severe systemic disease
8) Psychiatric disease
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Watanabe |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6104
nabeken@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Watanabe |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6104
Homepage URL
nabeken@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Akita University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University Graduate School of Medicine
Address
1-1-1 Hondo, Akita, Japan
Tel
018-884-6104
info@hos.akita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted at 18 collaborating medical institutions in Japan.
Management information
Registered date
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062608
