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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003911
Receipt No. R000004704
Scientific Title Study on medical treatment for patients with reflux esophagitis refractory to proton pump inhibitor
Date of disclosure of the study information 2010/07/20
Last modified on 2013/02/13

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Basic information
Public title Study on medical treatment for patients with reflux esophagitis refractory to proton pump inhibitor
Acronym Treatment for patients with reflux esophagitis refractory to proton pump inhibitor
Scientific Title Study on medical treatment for patients with reflux esophagitis refractory to proton pump inhibitor
Scientific Title:Acronym Treatment for patients with reflux esophagitis refractory to proton pump inhibitor
Region
Japan

Condition
Condition Reflux esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to evaluate treatment effect of omeprazole for patients with reflux esophagitis refractory to rabeprazole
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes in scores of Frequency scale for symptoms of gastroesophageal reflux diseases (FSSG)
Key secondary outcomes 1)Changes in scores of gastrointestinal symptom rating scale (GSRS)
2)Subgroup analysis for CYP2C19 genotype

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of omeprazole (20mg) for 56 days
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 gave a written consent to participate in this study
(2) Patients who were diagnosed as having erosive reflux esophagitis previously
(3) Patients who are receiving rabeprazole 10mg per day for more than 8 weeks
(4) Patients whose score of Frequency scale for symptoms of gastroesophageal reflux diseases (FSSG) are 8 or more points
Key exclusion criteria (1) Patients with the past history of digestive tract excisio and vagotomy
(2) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid weight loss
(3) Patients who have past history of or suffer from the following diseases: Zollinger-Ellison symdrome, inflammatory bowel disease, esophageal stenosis, achalasia, malabsorption, cerebrovascular disease such as cerebral hemorrhage or cerebral infarction
(4) Patients having severe liver, kidney or heart disease
(5) Patients who have malignancy or are suspected of having malignancy
(6) Patients who are pregnant, in breast-feeding or may have cecome pregnant
(7) Patients who need continuous medication of atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus, digoxin, methyldigoxin, itraconazole, Gefinitinib or voriconazole that might interact with the test drug
(8) Patients who are receiving proton pump inhibitors except rabeprazole
(9) Patients whom the doctor in charge judged to be unsuitable as an object of this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Fujita
Organization Kobe University Hospital
Division name Department of Gastroenterology
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6305
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Hospital
Division name Department of Gastroenterology
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology, Kobe University Hospital
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
2010 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 13 Day
Last modified on
2013 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004704

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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