UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002901 |
|---|---|
| Receipt number | R000003537 |
| Scientific Title | Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin-Randomized, Multi-center, single-blinded, parallel-group, comparative study- |
| Date of disclosure of the study information | 2009/12/15 |
| Last modified on | 2014/08/04 14:26:57 |
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Basic information
Public title
Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin-Randomized, Multi-center, single-blinded, parallel-group, comparative study-
Acronym
Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin (CARE Study)
Scientific Title
Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin-Randomized, Multi-center, single-blinded, parallel-group, comparative study-
Scientific Title:Acronym
Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin (CARE Study)
Region
| Japan |
Condition
Condition
Peptic Ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of PPI, comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Key secondary outcomes
Recurrence of gastrointestinal mucosal lesions (Lanza score more than 3), Lanza score and its changes form base line, compliance of low-dose aspirin consumption, the discontinuation rate due to insufficient efficacy of test drugs, mean changes of scores of GSRS, mean changes of scores of F-scale, changes of scores of SF-8, and incidence of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Rabeprazole sodium 10mg Tablet, oral administration once a day for 12 weeks.
Interventions/Control_2
Rabeprazole sodium 20mg Tablet. oral administration once a day for 12 weeks
Interventions/Control_3
Gefarnate 50mg Capsule oral administration twice a day for 12 weeks
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 ischemic heart failure or vascular disease of brain
2) patients taking low-dose aspirin to prevent relapse of vascular diseases
3) patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
4) patients without active gastric and duodenal ulcers
5) more than 20 years old
6) outpatients
7) patients written an informed consent
Key exclusion criteria
1) patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation, 2) patients with brain vascular disease, which are acute phase, unstable condition or under 3 months after the first attack, 3) patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator, 4) patients who are uncontrolled renal or liver dysfunction and unsuitable for this study as judged by investigator, 5) patients who are treated with steroid hormones, 6) patients who are women of, pregnant and lactating and childbearing, 7) Patients who are alcoholism, 8) patients who show the hypersensitivity for test drugs, 9) patients who are enrolled in another clinical study, 10) patients who are judged as unsuitable by investigator
Target sample size
285
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Azuma |
Organization
Kobe University
Division name
Medical Science in Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-6305
azumat@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Fujita |
Organization
Kobe University
Division name
Medical Science in Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-6305
Homepage URL
http://www.med.kobe-u.ac.jp/gicare/index.html
gcare@med.kobe-u.ac.jp
Sponsor or person
Institute
CARE Study Group
Institute
Department
Personal name
Funding Source
Organization
Non Profit Organization, Gastro-Intestinal Medical Care Research Center (GI-CARE)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
TRIGID0801
Org. issuing International ID_1
Foundation for Biomedical Research and Innovation Translational Research Informatics Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院（兵庫県）
六甲アイランド病院（兵庫県）
三田市民病院（兵庫県）
宍粟総合病院（兵庫県）
三木市民病院（兵庫県）
明石医療センター（兵庫県）
湯川胃腸病院（大阪府）
恵仁会田中病院（兵庫県）
神鋼病院（兵庫県）
神戸百年記念病院（兵庫県）
新日鐵広畑病院（兵庫県）
神鋼加古川病院（兵庫県）
吉田アーデント病院（兵庫県）
大阪府済生会中津病院（大阪府）
千船病院（大阪府）
高槻病院（大阪府）
京都第一赤十字病院（京都府）
福井大学医学部附属病院（福井県）
福井赤十字病院（福井県）
公立丹南病院（福井県）
大滝病院（福井県）
宮地内科（福井県）
ひらい医院（福井県）
福井社会保険病院（福井県）
中村病院（福井県）
東京医科大学附属病院（東京都）
獨協医科大学越谷病院（栃木県）
浜松医科大学附属病院（静岡県）
聖隷浜松病院（静岡県）
公立八鹿病院（兵庫県）
津山中央病院（岡山県）
神戸市立医療センター中央市民病院（兵庫県）
川崎病院（兵庫県）
神戸赤十字病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Rabeprazole is superior for reducing the risk of recurrence of peptic ulcer, esophagitis and gastrointestinal symptoms in long-term LDA users with a history of peptic ulcer.
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 | 02 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 15 | Day |
Last modified on
| 2014 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003537
