UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053282 |
|---|---|
| Receipt number | R000060248 |
| Scientific Title | Are changes in salivary secretion after taking vonoprazan involved in the pathogenesis of refractory gastroesophageal reflux disease? |
| Date of disclosure of the study information | 2024/01/09 |
| Last modified on | 2024/07/10 13:08:31 |
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Basic information
Public title
Are changes in salivary secretion after taking vonoprazan linked to treatment-resistant gastroesophageal reflux disease?
Acronym
effect of salivary secretion on reflux symptoms
Scientific Title
Are changes in salivary secretion after taking vonoprazan involved in the pathogenesis of refractory gastroesophageal reflux disease?
Scientific Title:Acronym
effect of salivary secretion on GERD
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nearly half of patients with gastroesophageal reflux disease (GERD) do not respond to proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB), which is the first-line treatment for GERD, due to factors such as hypersensitivity. We recently reported that the possible pathogenesis of PCAB-refractoriness in nearly 70% of the patients is hypersensitivity. However, there is no established treatment for esophageal hypercreativity.
A decrease in saliva production may be another possible pathogenesis of PPI/PCAB refractoriness since saliva is relevant in neutralizing acid refluxate. Patients with GERD, particularly those with PPI-refractory severe reflux esophagitis, have decreased saliva production. However, the effect of PPI/PCAB on salivary secretion and how it affects reflux pathophysiology remains unclear.
The post-reflux swallow-induced peristaltic wave index (PSPW) was suggested as an indicator of salivary swallow after reflux events on the 24-hour reflux monitoring. The PSPW index increased after PPI treatment in PPI-responsive GERD patients but not in PPI-resistant patients. This suggests that the salivary reflex is impaired even under PPI treatment in PPI-refractory patients. However, the correlation between PSPW and the volume of secreted saliva has not been reported. In addition, it is unclear whether PCAB shows the same effect on salivary secretion as PPI.
We hypothesized that salivary volume increases in the PCAB-responsive group after administration of vonoprazan, a type of PCAB, but not in the PCAB-refractory group and that salivary secretion correlates with PSPW on reflux monitoring. This study aims to (i) investigate changes in salivary secretion after PCAB administration, (ii) compare the difference in the change in salivary secretion after PCAB administration between the PCAB-responsive and refractory groups, and (iii) investigate a correlation between salivary volume and PSPW.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Change in salivary secretion after PCAB administration in PCAB-responsive patients.
Key secondary outcomes
We will investigate the flollowings:
1) change in salivary secretion after PCAB administration in PCAB-refractory patients.
2) correlation between saliva volume and PSPW index
3) correlation between saliva volume and other parameters of reflux monitoring test
4) Whether saliva volume is a predictor of PCAB efficacy. Logistic regression multivariate analysis will be performed using age, gender, and BMI as covariates. If other significant factors are found in the univariate analysis, the covariates will be changed or added.
5) changes in salivary pH and buffering capacity (pH change after acid loading) after PCAB administration.
6) correlation between changes in salivary volume and anxiety/depression, hypervigilance, and sleep scores
7) comparison of changes in salivary pH and buffering capacity between the PCAB responsive and refractory groups.
8) correlation between the symptomatic improvement effect of PCAB and objective GERD diagnosis by endoscopy and reflux monitoring tests.
10) correlation between the degree of mucosal damage at the esophagogastric junction under endoscopy and the objective diagnosis of GERD by reflux monitoring. correlation between the degree of mucosal damage and severity of reflux symptoms.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
28day treatment with vonoprazan 20mg
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 18 <= age <= 75
2. heartburn as a chief complaint
3. total score is 8 or more on the Frequency Scale for the Symptoms of GERD (FSSG)
Key exclusion criteria
1. Take medication that can influence the secretion of saliva, such as antiadrenergic agents and adrenergic alpha-2 agonists, antidepressants, psychotropic drugs, anticholinergic drugs, and smokers in the last two weeks before enrollment.
2. Take medication that affects the secretion of gastric acid, such as PPI, PCAB, and histamine H2 receptor antagonists in the last two weeks before enrollment.
3. Have scleroderma and Sjogren syndrome that can affect esophageal motility and saliva secretion.
4. Have current peptic ulcers.
5. Have an upper gastrointestinal surgery
6. Have severe complications such as heart disease or cancer.
7. Have an allergy to xylocaine.
8. Have an allergy to vonoprazan.
9. pregnant or lactating
10. Have an oral environment in which gum chewing is likely to cause dental problems, such as caries or unstable teeth
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Hoshikawa |
Organization
Nippon Medical School Graduate School of Medicine.
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi Bunkyo-ku Tokyo Japan
TEL
03-3822-2131
y-hoshiikawa@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Hoshikawa |
Organization
Nippon Medical School, Graduate School of Medicine.
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi Bunkyo-ku Tokyo Japan
TEL
03-3822-2131
Homepage URL
y-hoshiikawa@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, Graduate School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School, Graduate School of Medicine.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School, Ethics Committee
Address
1-1-5 Sendagi Bunkyo-ku Tokyo Japan
Tel
03-3822-2131
chuorinri.group@nms.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 | 01 | Month | 09 | 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
| 2023 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060248
