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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024833
Receipt No. R000028519
Scientific Title Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
Date of disclosure of the study information 2016/11/15
Last modified on 2017/07/06

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Basic information
Public title Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
Acronym Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
Scientific Title Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
Scientific Title:Acronym Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
Region
Japan

Condition
Condition nonsteroidal antiinflammatory drug induced small intestinal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the influence of differences in the type or dose of proton pump inhibitors (PPI) on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Number of mucosal breaks (erosion, ulcer) in the small intestine on capsule endoscopy at the completion of administration
Key secondary outcomes Number of sites of redness in the small intestine on capsule endoscopy at the completion of administration, Lewis score, fecal Calprotectin, serum DAO activity, and adverse effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diclofenac at 75 mg/day was orally administered after every meal (3 times a day), and vonoprazan at 20 mg after breakfast (once a day) for 14 days
Interventions/Control_2 Diclofenac at 75 mg/day was orally administered after every meal (3 times a day), and rabeprazole at 5 mg after breakfast (once a day) for 14 days
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who are not being orally treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (2) Those who are not being orally treated with PPI, H2 receptor antagonists, mucoprotective drugs, or prokinetics (3) Those from whom written informed consent regarding participation in this study was obtained.
Key exclusion criteria (1)a history of allergy to diclofenac, rabeprazole, vonoprazan (2)a history of peptic ulcers or gastrointestinal bleeding, ulcerative colitis, Crohn' s disease (3)a history of gastrointestinal surgery other than appendectomy (4)a history of intestinal obstruction or suspected gastrointestinal obstruction on other tests (5)significant hepatic, renal, heart, or respiratory disease (6)Pregnant women, those who may become pregnant during the study period, and lactating women (7)a lack of consent for the surgery required if the capsule endoscope was retained within the body (8)determination by the investigator (at his/her discretion) that the subject was ineligible for participation in the study for any other reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Higuchi Kazuhide
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2 7 Daigakumachi Takatsuki Osaka Japan
TEL 072-683-1221
Email higuchi@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Kojima
Organization Osaka Medical College
Division name Endoscopy Center
Zip code
Address 2 7 Daigakumachi Takatsuki Osaka Japan
TEL 072-683-1221
Homepage URL
Email in2134@osaka-med.ac.jp

Sponsor
Institute Second Department of Internal Medicine, Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
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 大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 11 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
terminate this trial to change the protocol
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
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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
2016 Year 11 Month 14 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028519

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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