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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006614
Receipt No. R000007822
Scientific Title A fact-finding study on the treatment of gastroesophageal reflux disease (GERD) -Investigation of response to proton pump inhibitor (PPI) therapy and factors involved-
Date of disclosure of the study information 2011/10/27
Last modified on 2014/04/02

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Basic information
Public title A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
-Investigation of response to proton pump inhibitor (PPI) therapy and factors involved-
Acronym A prospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
Scientific Title A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
-Investigation of response to proton pump inhibitor (PPI) therapy and factors involved-
Scientific Title:Acronym A prospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
Region
Japan

Condition
Condition Gastroesophageal reflux disease (GERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the response of gastroesophageal reflux disease (GERD) symptoms to proton pump inhibitor (PPI) therapy based on a patient questionnaire, and examine the extent of involvement of background factors that can affect treatment response
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Extent of involvement of individual background factors in the treatment response based on symptoms as measured using a patient questionnaire (GERD-TEST)
Key secondary outcomes (1) Differences in background factors between ERD patients and NERD patients
(2) Responses of ERD and NERD to PPI therapy
(3) Association between psychological bias and treatment response
(4) Association between GERD-TEST and SF-8
(5) Association among individual parameters observed or measured

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who have provided written consent of their own free will to participate in the study after receiving sufficient written or verbal information about the study
2) Patients of both sexes aged 20 years or above.
3) Patients with heartburn or acid regurgitation of moderate or higher severity occurring at least once a week, or that of mild severity occurring at least twice a week, during the two weeks prior to the start of the study
Key exclusion criteria 1) Patients with a history of gastrointestinal resection or vagotomy
2) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), or sudden weight loss
3) Patients with concurrent peptic ulcer (not in the scarring stage)
4) Patients with a prior or current history of any of the following diseases:
- Zollinger-Ellison syndrome
- Inflammatory bowel disease (IBD)
- Irritable bowel syndrome (IBS)
- Esophageal stricture
- Eosinophilic reflux esophagitis
- Esophageal achalasia
- Malabsorption
- Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction
5) Patients complicated by serious hepatic, renal, cardiac, or other diseases for which the participation in the study would be difficult
6) Patients with a confirmed or suspected malignant lesion
7) Patients who are pregnant, breastfeeding, or may be pregnant
8) Patients considered to require continued use of any drugs that could interact with the study drugs (i.e., atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, antacids containing aluminium hydroxide gel and magnesium hydroxide, and clopidogrel)
9) Patients with a history of hypersensitivity to any components of proton pump inhibitor products
10) Patients who received a proton pump inhibitor or an H2-receptor antagonist within one week prior to enrollment in this study
11) Patients who underwent H. pylori eradication within six months prior to the start of the study
12) Patients with any concurrent disease interfering with normal living (e.g., psychiatric disease, poorly controlled metabolic disease, neurological disease, collagen disease)
13) Other patients judged by the physician to be inappropriate for this study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Haruma
Organization Kawasaki Medical School
Division name Gastroenterology, Ultrasonology, and Translational Medicine & Nutrition
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization GERD Society
Division name Secretariat
Zip code
Address
TEL
Homepage URL
Email gerd@mcp.co.jp

Sponsor
Institute GERD Society
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 27 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 Completed
Date of protocol fixation
2011 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective nonrandomized multicenter observational study.
Patients with heartburn or acid regurgitation of moderate or higher severity occurring at least once a week, or that of mild severity occurring at least twice a week, during the two weeks prior to the start of the study are asked to answer the questionnaire before and after PPI medication.
1) Drugs for PPI therapy
Omeprazole tablet 20mg
Lansoprazole Capsule or OD tablet 30mg
Rabeprazole tablet 10mg or 20mg
2) Administration
Once daily oral administration
3) Administration period
4 weeks
4) Questionnaire
GERD-TEST, SF-8, HADS

Management information
Registered date
2011 Year 10 Month 26 Day
Last modified on
2014 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007822

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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