UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040806 |
|---|---|
| Receipt number | R000046245 |
| Scientific Title | Effect of salivary secretion on the onset of PPI-resistant severe reflux esophagitis |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2021/01/07 17:47:04 |
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Basic information
Public title
Effect of salivary secretion on the onset of reflux esophagitis
Acronym
Salivary secretion and refractory reflux esophagitis
Scientific Title
Effect of salivary secretion on the onset of PPI-resistant severe reflux esophagitis
Scientific Title:Acronym
Salivary secretion and refractory reflux esophagitis
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of salivary secretion (volume, pH, acid-buffering capacity) on the onset of PPI-resistant severe reflux esophagitis
Basic objectives2
Others
Basic objectives -Others
Effect of salivary epidermal growth factor (EGF) on the onset of PPI-resistant severe reflux esophagitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Volume of stimulated saliva
pH of stimulated saliva
acid-buffering capacity
salivary epidermal growth factor (EGF) concentration
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patientes who have had standard-dose oral PPI therapy over 8 weeks
2. Patients who have been diagnosed with severe reflux esophagitis before PPI therapy
3. Pylori negative patients
4. Patients who have not been diagnosed with gastrotic mucosal atrophy (C-1 or C-2)
5. Patiens who have endoscopic hernia bigger than 2cm
Key exclusion criteria
except as mentioned above
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Iwakiri |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
k-iwa@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tomohide |
| Middle name | |
| Last name | Tanabe |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
tanabe@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nippon Medical School Hospital
Address
1--1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
tanabe@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
| 2020 | Year | 06 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The effect of salivary secretion on the onset of PPI-resistant severe reflux esophagitis has not been examined. In this study, the influences of stimulated saliva secretion and salivary EGF associated with healing of esophageal mucosal break on the development of PPI-resistant severe reflux esophagitis were investigated.
Management information
Registered date
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046245
