UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015731 |
|---|---|
| Receipt number | R000018305 |
| Scientific Title | Irsogladine maleate and rabeprazole in non-erosive reflux disease - a double-blind, placebo- controlled study |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2014/11/21 15:13:48 |
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Basic information
Public title
Irsogladine maleate and rabeprazole in non-erosive reflux disease - a double-blind, placebo- controlled study
Acronym
Irsogladine maleate and rabeprazole in NERD
Scientific Title
Irsogladine maleate and rabeprazole in non-erosive reflux disease - a double-blind, placebo- controlled study
Scientific Title:Acronym
Irsogladine maleate and rabeprazole in NERD
Region
| Japan |
Condition
Condition
NERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of adding irsogladine maleate to PPI therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FSSG(frequency scale for the symptoms of GERD)
Key secondary outcomes
SF-36(MOS Short-Form 36-Item Health Survey)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole plus irsogladine maleate
Interventions/Control_2
rabeprazole plus placebo
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
Patients with persistent GERD symptoms were enrolled to participate in the study if they did not have mucosal breaks in their esophagi, and if they had Frequency Scale for Symptoms of GERD (FSSG) scores of 8 or more than 8.
Key exclusion criteria
Patients were excluded from the study if they were younger than 20 years, were allergic to rabeprazole or IM, had any level of esophagitis determined by gastrointestinal endoscopy, were pregnant, were taking anti-coagulant or anti-platelet agents, had a history of gastrointestinal malignancy, peptic ulcers, or gastrointestinal tract surgery, or if they had used any PPI therapy within four weeks of enrolling in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayoshi Suzuki |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology & Hepatology
Zip code
Address
143 Shimokasuya Isehara, Kanagawa, 259-1193 Japan
TEL
0463-93-1121
takayosh@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayoshi Suzuki |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology & Hepatology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa, Japan 259-1193
TEL
0463-93-1121
Homepage URL
takayosh@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
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
| 2014 | Year | 11 | Month | 21 | 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
| 2008 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 21 | Day |
Last modified on
| 2014 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018305
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
