UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
Title of the study (Brief title)	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	Higuchi Kazuhide
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2 7 Daigakumachi Takatsuki Osaka Japan
TEL	072-683-1221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	Yuichi Kojima
Organization	Osaka Medical College
Division name	Endoscopy Center
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	terminate this trial to change the protocol
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