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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029957
Receipt No. R000034163
Scientific Title Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis
Date of disclosure of the study information 2018/01/15
Last modified on 2018/11/14

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Basic information
Public title Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis
Acronym Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis
Scientific Title Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis
Scientific Title:Acronym Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis
Region
Japan

Condition
Condition reflux esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Change of frequency and grade of GERD symptom after discontinuation of a Proton Pump Inhibitor in Reflux-Esophagitis is exploratory investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Investigate the correlation between FSSG total score change and H. pylori infection, pepsinogen I / II ratio, bloody gastrin value, sex, age, BMI, smoking, esophageal hiatal hernia.
Key secondary outcomes Number of days to symptom onset. (symptoms diary)
Investigate factors on affecting GSRS score including subscale, FSSG (reflux, motility) score, and HADS (depression) score value of change exploratory.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention: For measurement of blood gastrin, blood H. pylori antibody, blood pepsinogen, 3 ml of blood is collected from subjects registered before drug withdrawal. Also, ask the subject to fill out GSRS, FSSG, HADS questionnaire as a symptom questionnaire, hand the patient's diary for symptomatic investigation to the subject, and ask the subject to fill in before bedtime everyday. Symptoms brought during visit 4 weeks after the questionnaire and symptom diary were collected from the subjects and 3 ml of blood was collected for each gastrin measurement from the subjects. After completing the survey of the subject, the researcher records the patient's background in the questionnaire and keeps it with the symptom questionnaire (GSRS, FSSG, HADS). Participating facilities other than our university will send blood specimens and survey forms to the secretariat.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Reflux esophagitis of LA grade A or B.
(2) Patients undergoing treatment for more than 1 month at maintenance therapy for reflux esophagitis of Acid inhibitors (H2 receptor antagonist, proton pump inhibitor, potassium competitive acid blocker).
(3) Patient with FSSG total score less than 8 points.
(4) aged 20 years or older. Gender does not matter
(5) Patients agreeing to participate in this study
Key exclusion criteria 1.Refractory reflux esophagitis which resistant treatment for more than 4 weeks with PPI or P-cab
2.Patients with peptic ulcer
3.Patients in need of treatment due to functional dyspepsia, irritable bowel syndrome, inflammatory bowel disease complicated.
4.Patients with Zollinger-Ellison syndrome, advanced atrophic gastritis (Kimura Takemoto classification: O3) or malignant anemia.
5.Patients with a history of upper gastrointestinal resection or vagotomy.
6.Patients with warning findings such as vomiting, gastrointestinal bleeding (including findings of hematemesis, venous drainage, anemia, etc.), suddenly weight loss.
7.Patients with malignant finding confirmed or suspected
8.Patients in need of treatment (PPI, P-cab, H2RA, Gastrointestinal motility drug including Rikkunshito, Anticholinergic, Antidepressant, anxiolytic, Steroid excluding external preparations , Regular use of NSAID, aspirin preparation including low dose aspirin, bisphosphonate, calcium RA) during the study period.
9.Patients complicated with severe liver disease, kidney disease, heart disease etc.
10.Other patients who are considered inappropriate for study by investigaters
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email Higuchi@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihisa Takeuchi
Organization Osaka Medical College
Division name Endoscopy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email in2097@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Astra Zeneca K.K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka Medical college Mishima Minami Hospital, Hirata city Hospital, Hokusetsu General Hospital, Daiichi Towakai Kai Hospital, Ishikiri-Seiki Hospital, Shitenno-ji Hospital, Aoyama Hospital, Hanwa Sumiyoshi General Hospital, Shiroyama Hospital, Seikeikai Hospital, Tatsumi Hospital, Sousei Hospital, Taisho Hospital, Keijinkai Moriguchi Hospital, Katsuragi Hospital, Midorigaoka Hospital, Osaka Kaisei Hospital, Kashiba-seiki Hospital, Rakusai Shimizu Hospital, Otowa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪医科大学病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 15 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
2017 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 13 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034163

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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