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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010063
Receipt No. R000011785
Scientific Title Investigation of the factors related to PPI refractory GERD and the effect of switching PPI
Date of disclosure of the study information 2013/02/19
Last modified on 2013/02/18

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Basic information
Public title Investigation of the factors related to PPI refractory GERD and the effect of switching PPI
Acronym The factors related to PPI refractory GERD
Scientific Title Investigation of the factors related to PPI refractory GERD and the effect of switching PPI
Scientific Title:Acronym The factors related to PPI refractory GERD
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 investigate the factors related to PPI refractory GERD, particularly both from psychological aspect and metabolism of treatment drug.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Factors that may affect treatment with omeprazole 20mg/day for eight weeks
(e.g.. age, gender, duration of GERD, H.pylori infection, hiatus hernia, and Hospital Anxiety and Depression Scale [HADS] score and Cyp2C19 genotype.)
Key secondary outcomes 1) Effect of symptom improvement after the administration of 20mg/day Omeprazole for eight weeks
2) Effect of symptom improvement after switching of 20mg/day Rabeprazole for 8 weeks

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 rabeprazole(20mg/day) for eight weeks
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 given a written consent to participate in this study
(2) Patients who were diagnosed as having erosive reflux esophagitis within six months before registration
(3) Patients who have been receiving omeprazole 20mg per day for more than 8 weeks
(4) Patient who can answer Frequency scale for symptoms of gastroesophageal reflux diseases (FSSG) questionnaire and Hospital Anxiety and Depression Scale (HADS) score
Key exclusion criteria (1) Patients who have past history of or suffer from the following diseases: Zollinger-Ellison symdrome, inflammatory bowel disease, irritable bowel syndrome, achalasia, malabsorption
(2) Patients with the past history of digestive tract excisio and vagotomy
(3) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid weight loss
(4) The patient who is complicated with peptic ulcer (gastric ulcer, duodenal ulcer)
(5) Patients having severe liver, kidney or heart disease
(6) Patients who have malignancy or are suspected of having malignancy
(7) Patients who underwent Helicobacter pylori eradication within two months prior to the registration
(8) Patients who are pregnant, breastfeeding, or may be pregnant
(9) Patients who need continuous medication of atazanavir sulfate, digoxin, methyldigoxin, itraconazole, Gefinitinib or antacids containing aluminium hydroxide gel and magnesium hydroxide, that might interact with the test drug
(10) Patients who are receiving H2 receptor blocker, prokinetic agent , gastroprotective agent, cholinolytic, antacid, antidepressant, antianxiety drug, steroid (except the agent for outside), bisphosphonate
(11) Patients whom the doctor in charge judged to be unsuitable as an object of this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Internal Medicine, Osaka Medical College
Division name 2nd Department
Zip code
Address 2-7 Daigaku-machi, Takatsuki-City, Osaka 569-8686, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihisa Takeuchi
Organization Internal Medicine, Osaka Medical College
Division name 2nd Department
Zip code
Address
TEL
Homepage URL
Email in2097@poh.osaka-med.ac.jp

Sponsor
Institute 2nd Department of Internal Medicine, Osaka Medical College
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
2013 Year 02 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 Completed
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 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

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2013 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011785

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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