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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005766
Receipt No. R000006810
Scientific Title Prophylactic use of low-dose PPI and recurrence of upper gastro-intetinal peptic ulcer in long-term Users of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or low-dose aspirin(LDA)
Date of disclosure of the study information 2011/06/15
Last modified on 2016/06/15

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Basic information
Public title Prophylactic use of low-dose PPI and recurrence of upper gastro-intetinal peptic ulcer in long-term Users of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or low-dose aspirin(LDA)
Acronym Prophylactic use of low-dose PPI and recurrence of upper gastro-intetinal peptic ulcer in long-term Users of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or low-dose aspirin(LDA)
Scientific Title Prophylactic use of low-dose PPI and recurrence of upper gastro-intetinal peptic ulcer in long-term Users of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or low-dose aspirin(LDA)
Scientific Title:Acronym Prophylactic use of low-dose PPI and recurrence of upper gastro-intetinal peptic ulcer in long-term Users of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or low-dose aspirin(LDA)
Region
Japan

Condition
Condition Peptic Ulcer
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose of this study is to examine influences by switching from standard-dose PPI regimen to half-dose lansoprazole(15 mg) regimen for peptic ulcer prevention.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence rate of gastric or duodenal ulcer after treatment (gastrointestinal mucosal disorder with a lesion greater than or equal to 5 mm in diameter)
Key secondary outcomes Changes in digestive symptom(GSRS) and gastro-intestinal mucosal injury (Mofified Lanza-Score), Incidence rate of Gastroesophageal reflux disease

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 changing to lansoprazole 15 mg
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients taking NSAIDs or LDA for more than a month
2)Patioents taking standard-dose PPI(omeprazole20mg,lansoprazole30mg, rabeprazole10mg)
3)Patients with past history of endoscopically documented gastric or duodenal ulcer
4)Patients with written informed consent
Key exclusion criteria 1) Patients with allergy for lansoprazole
2)Patients with allergy of atazanavir sulfate
3) Patients under treatment of peptic ulcer
4)Over Grade A reflux esophagitis according to Los Angeles classification (LA classification)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Watanabe
Organization Osaka City University Graduate School of Medicine
Division name Deaprtment of Gastroenterology
Zip code
Address 1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL 06-6645-3811
Email ttanigawa@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Tanigawa
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL 06-6645-3811
Homepage URL
Email ttanigawa@med.osaka-cu.ac.jp

Sponsor
Institute Department of Gastroenterology, Osaka City University Graduate School of Medcine
Institute
Department

Funding Source
Organization Department of Gastroenterology, Osaka City University Graduate School of Medcine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 06 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 Terminated
Date of protocol fixation
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 13 Day
Last modified on
2016 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006810

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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