UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017347 |
|---|---|
| Receipt number | R000020130 |
| Scientific Title | Correlation between inhibited gastric secretion level and residual symptoms in GERD patients refractory to PPI |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/04/30 17:27:58 |
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Basic information
Public title
Correlation between inhibited gastric secretion level and residual symptoms in GERD patients refractory to PPI
Acronym
Correlation between inhibited gastric secretion level and residual symptoms in GERD patients refractory to PPI
Scientific Title
Correlation between inhibited gastric secretion level and residual symptoms in GERD patients refractory to PPI
Scientific Title:Acronym
Correlation between inhibited gastric secretion level and residual symptoms in GERD patients refractory to PPI
Region
| Japan |
Condition
Condition
GERD patients on ordinary dose of PPI
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between inhibited gastric secretion level and residual symptom in GERD patients on PPI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of gastric acid secretion during PPI administration between GERD patients with and those without residual symptoms
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
PPI treatment
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
GERD patients on ordinary dose of PPI
Key exclusion criteria
1. PPI compliance lower that 90%
2. taking other anti-secretory drugs, prokinetics, or anti-psychotis
3. GERD afer upper GI surgery
4. long-segment (more than 3 cm) Barrett's esophagus
5. taking NSAIDs or aspirin
6 receiving H. pylori eradication within 1 year
7. serious systematic diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Iijima |
Organization
Tohuku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai 980-8574, Japan.
TEL
022-717-7171
kiijima@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunori Iijima |
Organization
Tohuku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai 980-8574, Japan.
TEL
022-717-7171
Homepage URL
kiijima@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohuku University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2015 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020130
