UMIN-CTR Clinical Trial

Basic information
Public title	Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study
Acronym	Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury
Scientific Title	Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study
Scientific Title:Acronym	Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury
Region	Japan

Condition
Condition	LDA-induced small intestinal mucosal injury
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this clinical study was to investigate how high-dose ES affects LDA-induced small intestinal mucosal injury.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Severity of small intestinal mucosal injury using small bowel capsule endoscopy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The subjects in group A received LDA (100 mg) once daily.
Interventions/Control_2	The subjects in group B received LDA and 4.0 g of ES (1.0 g four times daily).
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) freely provided informed consent on the basis of their full understanding of the study protocol, and 2) had no history of medication use during the month before enrolment in the study
Key exclusion criteria	1) history of peptic ulcer or gastrointestinal bleeding; 2) significant hepatic, renal, heart, or respiratory disease; 3) history of gastrointestinal surgery other than appendectomy; 4) use of oral histamine H2-receptor antagonists, gastrointestinal kinetic agents, and gastric mucoprotective drugs within 2 weeks before the study; 5) use of oral non-steroidal anti-inflammatory drugs (NSAIDs), steroids, anticholinergic drugs, anticancer drugs, or antithrombotic drugs within 4 weeks prior; 6) alcohol or chemical dependency; 7) history of gastrointestinal obstruction; 8) refusal to consent to the surgery that would be required if the capsule endoscope was retained in the body; and 9) determination by the investigator, at his/her discretion, that a subject was ineligible for participation in the study for any reason.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhide Higuchi
Organization	Osaka medical college
Division name	Second department of internal medicine
Zip code
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Ota
Organization	Osaka medical college
Division name	Second department of internal medicine
Zip code
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Homepage URL
Email	clash_kaz@yathoo.co.jp

Sponsor
Institute	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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 01 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	Completed
Date of protocol fixation	2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 01 Day
Last modified on	2018 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038751

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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