UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007116 |
|---|---|
| Receipt number | R000008387 |
| Scientific Title | Effect of esomeprazole on symptom relief in patients with PPI-refractory GERD |
| Date of disclosure of the study information | 2012/01/23 |
| Last modified on | 2015/02/23 13:03:04 |
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Basic information
Public title
Effect of esomeprazole on symptom relief in patients with PPI-refractory GERD
Acronym
Effect of esomeprazole on symptom relief in patients with PPI-refractory GERD
Scientific Title
Effect of esomeprazole on symptom relief in patients with PPI-refractory GERD
Scientific Title:Acronym
Effect of esomeprazole on symptom relief in patients with PPI-refractory GERD
Region
| Japan |
Condition
Condition
PPI-refractory GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although PPI is the first-line treatment for GERD, there is some cases with PPI failure. The aim of the study is to examine effect of esomeprazole, recently apperaed in Japanese market, on symptom relief in such cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Imrovement rate in GerdQ 4 weeks after esopmerazole treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 with IC
2. Diagnosis as having reflux esophagitis by endoscopy during the past 12 months
3. 2-3 days and more in atleast one of Q1, Q2, Q5, Q6 of GerdQ
Key exclusion criteria
1. Esomeprazole allergy
2. Prescribing atazanavir sulfate
3. Esophageal stricture, IBS, IBD, Zollinger-Ellison syndrome, Malabsorption syndrome
4. Active gastric or duodenal ulcer by endoscopy
5. Sever Heart, kideny, liver diseases
6. Upper GI surgery
7. Pregnancy
8. PPI administration 14 days before trial
9. Co-treatment with H2RA, prokinetcis, other PPI etc.
10.Other drugs (diazepam, digoxin, etc.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujiwara |
Organization
Osaka City University
Division name
Gastroentereology
Zip code
Address
1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University
Division name
Gastroentereology
Zip code
Address
TEL
Homepage URL
yasu@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Gastroentereology
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
| 2012 | Year | 01 | Month | 23 | 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
| 2011 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although PPI is the firstline treatment for GERD, there are some cases with PPI failure. The aim of the study is to examine effect of esomeprazole on symptoms relief in such cases by using specific symptom questionnaire and GERD-related QOL score (GerdQ).
Management information
Registered date
| 2012 | Year | 01 | Month | 23 | Day |
Last modified on
| 2015 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008387
