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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name