UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003911 |
|---|---|
| Receipt number | 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 09:52:51 |
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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
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
Sponsor or person
Institute
Department of Gastroenterology, Kobe University 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004704
