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Recruitment status Completed
Unique ID issued by UMIN UMIN000002901
Receipt No. 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

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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
Email 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
Email gcare@med.kobe-u.ac.jp

Sponsor
Institute CARE Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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