UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020701 |
|---|---|
| Receipt number | R000023888 |
| Scientific Title | The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma |
| Date of disclosure of the study information | 2016/01/22 |
| Last modified on | 2018/09/23 21:48:37 |
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Basic information
Public title
The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Acronym
The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Scientific Title
The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Scientific Title:Acronym
The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Region
| Japan |
Condition
Condition
reflux esophagitis associated with systemic scleroderma
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The efficacy of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Key secondary outcomes
The safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
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 |
Interventions/Control_1
Rabeprazole sodium 1 tablet a day will be added to subjects whose symptom does not improve with 1 tablet a day. The study will continue until subjects meet discontinuance criteria.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with systemic sclerosis who have reflux esophagitis diagnosed by upper gastrointestinal endoscopy or esophagus scintigraphy and daily 10mg of oral rabeprazole sodium is not effective for more than two months.
Patients who have no malignant lesions in the upper-gastrointestinal tract confirmed by endoscopy.
Patients who give written informed consent.
Key exclusion criteria
Patients who have a severe difficulty swallowing and who are unable to take orally the tablet.
Patients who are judged to be inappropriate as a subject by physicians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhito Hamaguchi |
Organization
Faculty of Medicine,
Institute of Medical, Pharmaceutical and Health Sciences,
Kanazawa University
Division name
Dermatology
Zip code
Address
Takaramachi 13-1, Kanazawa
TEL
076-265-2343
yasuhito@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhito Hamaguchi |
Organization
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name
Dermatology
Zip code
Address
Takaramachi 13-1, Kanazawa
TEL
076-265-2343
Homepage URL
yasuhito@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine,
Institute of Medical, Pharmaceutical and Health Sciences,
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine,
Institute of Medical, Pharmaceutical and Health Sciences,
Kanazawa University
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 22 | 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
| 2005 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Subject: Patients who visit to Kanazawa University Hospital
Management information
Registered date
| 2016 | Year | 01 | Month | 22 | Day |
Last modified on
| 2018 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023888
| 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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