UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033984
Receipt number R000038751
Scientific Title Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study
Date of disclosure of the study information 2018/09/01
Last modified on 2018/09/01 13:21:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Osaka medical college

Institute

Department

Personal name



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

Value
https://center6.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