UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009398 |
|---|---|
| Receipt number | R000011042 |
| Scientific Title | To evaluate treatment efficacy after switching medication in reflux esophagitis patients who have parsistent gastro- esophageal reflux symptoms despite standard PPI therapy |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2015/06/05 09:19:13 |
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Basic information
Public title
To evaluate treatment efficacy after switching medication in reflux esophagitis patients who have parsistent gastro- esophageal reflux symptoms despite standard PPI therapy
Acronym
To evaluate treatment efficacy after switching medication in PPI refractory GERD patients
Scientific Title
To evaluate treatment efficacy after switching medication in reflux esophagitis patients who have parsistent gastro- esophageal reflux symptoms despite standard PPI therapy
Scientific Title:Acronym
To evaluate treatment efficacy after switching medication in PPI refractory GERD patients
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(Primary) Symptom suppression after switching to esomeprazole 20 mg will be investigated using a self-administering questionnaire, Frequency Scale for the Symptoms of GERD (FSSG), in refractory reflux esophagitis patients with residual symptoms despite being on the standard dose of an existing PPI (omeprazole 20 mg, lansoprazole 30 mg, or rabeprazole 10 mg) for at least 8 weeks.
(Secondary) The pathological condition of each patient will be closely investigated through 24-hr pH/MII monitoring before starting esomeprazole treatment (baseline 24-hr pH/MII monitoring) to assess the relationship between pathological factors and symptom suppression after switching to esomeprazole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the FSSG score at Week 2 of esomeprazole treatment
Key secondary outcomes
1. Change in the FSSG score at Week 2 of esomeprazole treatment by pathological factor revealed through baseline 24-hr pH/MII monitoring
(the change in the FSSG score will be evaluated for each of the following pathological factors)
I. SI positive or negative
II. Presence or absence of pathological acid reflux
2. Percentage of subjects with insufficient treatment response as confirmed by the GerdQ at Week 2
Percentage of subjects with gastroesophageal reflux symptoms at least 1 day per week at Week 2
3. Patient background factors that affect the change rate of the FSSG score after starting esomeprazole treatment
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 | Device,equipment |
Interventions/Control_1
Baseleine 24-hr pH/MII monitoring
20mg-esomeprazole
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) The patient provides written voluntary consent to participate in the study after sufficient written and oral explanations.
(2) The patient is a man or woman aged 20 years or older.
(3) The patient has refractory reflux esophagitis and has been on the standard dose of an existing PPI (omeprazole 20 mg, lansoprazole 30 mg, or rabeprazole 10 mg) for at least 8 weeks prior to screening.
(4) The patient does not sufficiently respond to the treatment as confirmed by the Treatment Response, GerdQ questionnaire.
Key exclusion criteria
(1) The patient has warning signs such as vomiting and gastrointestinal hemorrhage.
(2) The patient needs to continue any drug that might interact with esomeprazole.
(3) The patient previously had or currently has any of the following diseases.
Zollinger-Ellison syndrome
Esophageal stenosis
Esophageal achalasia
Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction
(4) The patient has any serious hepatic, renal, or cardiac disease that makes participation in the study difficult in the opinion of the investigator.
(5) The patient has a confirmed or suspected malignant lesion.
(6) The patient is a pregnant, nursing, or possibly pregnant woman.
(7) The patient is otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiaki Yano |
Organization
The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo 105-8461
TEL
03-3433-1111
f-yano@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiaki Yano |
Organization
The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo 105-8461
TEL
03-3433-1111
Homepage URL
f-yano@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Organization for GastroEnterological disease Treatment (ROGET)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
東京都慈恵会医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 01 | 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
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
| 2012 | Year | 11 | Month | 26 | Day |
Last modified on
| 2015 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011042
