UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005602 |
|---|---|
| Receipt number | R000006621 |
| Scientific Title | The Effect of Rebamipide for the Patients with Reflux Esophagitis and Gastritis |
| Date of disclosure of the study information | 2011/05/15 |
| Last modified on | 2016/06/05 15:09:28 |
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Basic information
Public title
The Effect of Rebamipide for the Patients with Reflux Esophagitis and Gastritis
Acronym
Effect of Rebamipide
Scientific Title
The Effect of Rebamipide for the Patients with Reflux Esophagitis and Gastritis
Scientific Title:Acronym
Effect of Rebamipide
Region
| Asia(except Japan) |
Condition
Condition
Phase IV, multi-center, randomized, open-labeled, comparison study
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of rebamipide by investigating its symptomatic response in patients with reflux esophagitis and gastritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of a total symptom score after four-week administration of esomeprazole and rebamipide
Key secondary outcomes
The mean decrease in the total symptom score at 4 weeks since trial medicine, the change from baseline of reflux symptoms (heartburn and regurgitation), the proportion of patients with at least a 50% decrease in the symptoms score compared with their baseline score, and the proportion of patients reporting complete improvement of symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group is treated by rebamipide and esomeprazole
Interventions/Control_2
Control group is treated by esomeprazole
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adults aged over 20 years and less 70 years
2) Patients diagnosed as reflux esophagitis through esophagogastroduodenoscopy
3) Patients signing the informed consent document of this clinical study
Key exclusion criteria
1) Pregnant or lactating women, child bearing women not using a proper contraception
2) Patients with history of gastrointestinal surgery
3) Patients with gastric ulcer or duodenal ulcer
4) Patients with significant impairment in the heart, the lung, the blood or the endocrine system
5) Patients with psychiatric disorders or alcohol or drug addiction
6) Patients who are considered to be unsuitable by investigator(s) because of other reason
Target sample size
492
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soo Heon Park |
Organization
The Catholic University of Korea College of Medicine, Seoul, Korea.
Division name
Department of Internal Medicine
Zip code
Address
62, Yeouido-dong, Yeongdeungpo-gu, Seoul, Korea
TEL
82-2-3779-1163
psheon5132@naver.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine, Seoul, Korea
Division name
Department of Internal Medicine
Zip code
Address
1174 Jung-dong Wonmi-gu, Bucheon, Korea
TEL
82-32-621-5087
Homepage URL
sjhong@schmc.ac.kr
Sponsor or person
Institute
Korean College of Helicobacter and Upper Gastrointestinal Research
Institute
Department
Personal name
Funding Source
Organization
NO
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
Yeouido St. Mary's hospital (Seoul, Korea), Soonchunhyang University Bucheon Hospital(Bucheon, Korea), Chung-ang University Medical Center(Seoul, Korea), Seoul National University Bundang Hospital(Seongnam), Samsung Medical Center(Seoul, Korea), Inje University Seoul Paik Hospital(Seoul, Korea), Korea University Ansan Hospital(Ansan, Korea), Severance Hospital(Seoul, Korea), Hanyang University Hospital(Seoul, Korea), Kyung Hee University Hospital(Seoul, Korea), Hallym University Kangdong Sacred Heart Hospital(Seoul, Korea), Ruijin Hospital(China), 1st Affiliated Hospital of Anhui Meical University (China), 2nd Affiliated Hospital of Wenzhou Medical University (China), Tianjin General Hospital(China), Eastern Hospital (China), Siriraj Hospital of Mahidol University (Thailand), Cardinal Santos Medical Center (The Philippines)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 15 | 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 | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 15 | Day |
Last modified on
| 2016 | 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=R000006621
