UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029032 |
|---|---|
| Receipt number | R000033210 |
| Scientific Title | Study on the symptom control of gastric acid suppressive drugs in reflux esophagitis patients |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2019/12/13 11:12:34 |
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Basic information
Public title
Study on the symptom control of gastric acid suppressive drugs in reflux esophagitis patients
Acronym
Study on the recurrent symptom after suspension of therapy with gastric acid suppressive drugs in reflux esophagitis patients
Scientific Title
Study on the symptom control of gastric acid suppressive drugs in reflux esophagitis patients
Scientific Title:Acronym
Study on the recurrent symptom after suspension of therapy with gastric acid suppressive drugs in reflux esophagitis patients
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the recurrent symptom at 2 weeks after suspension of therapy with vonoprazan or esomeprazole in patients with reflux esophagitis using Gerd Q score of heartburn and acid regurgitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gerd Q total score of heartburn and acid regurgitation
Key secondary outcomes
1. Gerd Q each score of heartburn and acid regurgitation
Degrees of heartburn and acid regurgitation
2. Gerd Q each score of epigastralgia, nausea and vomiting
Degrees of epigastralgia, nausea and vomiting
3. Evaluation of treatment response with Gerd Q
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Suspension of therapy with vonoprazan
Interventions/Control_2
Suspension of therapy with esomeprazole
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have freely provided written informed consent for the participation of this study after the oral and written sufficient explanation
2. Patients diagnosed as having reflux esophagitis by physician, and receiving the therapy with vonoprazan or esomeprazole for 4 weeks or longer
3. Patients who check 0 day a week in GerdQ Q1 and Q2
Key exclusion criteria
1. Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), and sudden weight loss
2. Patients confirmed or suspected malignant lesion
3. Patients with a history of gastrointestinal resection or vagotomy
4. Patients in Irritable Bowel Syndrome
5. Patients whose participation in this study would be contraindicated due to complications such as serious hepatic disease, renal disease, or cardiac disease
6. Women who are pregnant or who may possibly be pregnant, and lactating mothers
7. Other patients whom the investigator considers unsuitable for admission to the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Mizuno |
Organization
Marru-clinic Yokosuka
Division name
Department of Gastroenterology
Zip code
238-0011
Address
Kyoritsu Yonegahama Building 5F, 1-8-7, Yonegahamadori, Yokosuka, Kanagawa, Japan
TEL
+81-46-828-5333
mizunoy3000@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Mizuno |
Organization
Marru-clinic Yokosuka
Division name
Department of Gastroenterology
Zip code
238-0011
Address
Kyoritsu Yonegahama Building 5F, 1-8-7, Yonegahamadori, Yokosuka, Kanagawa, Japan
TEL
+81-46-828-5333
Homepage URL
mizunoy3000@gmail.com
Sponsor or person
Institute
Marru-clinic Yokosuka
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Self funding
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
Marru-clinic Yokosuka
Address
Kyoritsu Yonegahama Building 5F, 1-8-7, Yonegahamadori, Yokosuka, Kanagawa, Japan
Tel
+81-46-828-5333
mizunoy3000@gmail.com
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
| 2017 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
30
Results
In the results, between the PCAB (5 cases/30 cases, 33%) and PPI (6 cases/30 cases, 40.0%) groups in the proportion of patients with a positive symptom score of at least 1 point at 2 weeks after discontinuation, there was no statistically significant difference (chi-square test, p = 0.705) . Negative symptom scores were not also statistically significantly different between the PCAB (7 cases, 46%) and PPI (4 cases, 26.7%) groups (chi-square test, p = 0.256).
Results date posted
| 2019 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 29 | Day |
Baseline Characteristics
Patients diagnosed of GERD between December 2017 and April 2018 at the Marru-clinic Yokosuka, who continued oral administration of PCAB or PPI for more than 4 weeks, and whose symptoms subsided.
Participant flow
Patients were examined for GERDQ scores after cessation of oral administration.
Adverse events
symptoms or abnormal findings were collected
Outcome measures
postitive symptom score, total GERD Q score, negative symptom score, positive impact score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033210
