UMIN-CTR Clinical Trial

Public title

Effects of rebamipide on healing of low-dose aspirin-induced small intestinal mucosal injury- A pilot study-

Acronym

CREAM Study(Cytoprotection by Rebamipide on Aspirin-induced Mid-GI damage.)

Scientific Title

Effects of rebamipide on healing of low-dose aspirin-induced small intestinal mucosal injury- A pilot study-

Scientific Title:Acronym

CREAM Study(Cytoprotection by Rebamipide on Aspirin-induced Mid-GI damage.)

Region

Japan

Condition

small intestinal injury

Classification by specialty

Gastroenterology

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of rebamipide on healing of small intestinal mucosal injury caused by low-dose aspirin.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Capsule endoscopic findings (number of ulcers/erosions)

Key secondary outcomes

Lewis Score
Symptom assessment (anemia, melena, complications)
Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients in the treatment group receive rebamipide (900 mg/day) for 8 weeks.

Interventions/Control_2

Patients in the control group receive placebo for 8 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) The subject who agree to participate in the study by written informed consent.
2) The subjects taking aspirin enteric-coated tablets (Bayaspirin 100 tablet) for more than three months and planning to continue it for more than eight weeks.
3) The subjects who have ischemic heart disease and cerebrovascular diaseases and they are stable.
4) The subjects from age 20 to 75 years old.
5) We do not ask you sexuality.
6) The subjects proven to have small intestinalmucosal injury by capsule endoscopy.

Key exclusion criteria

1) Subjects with the diseases which induce small intestinal injury such as Chrohn's disease, gastrointestinal stromal tumor, small intestinal tumor.
2) The subject taking drugs which have potential to induce small intestinal injury such as NSAIDs, anticancer drugs.
3) The subject taking antibiotics, sulfasalazine, prostaglandin analog, corticosteroids, free radical depressant, elastase depressant, mucoprotective drugs and drugs which have potential to improve small intestinal injury.
4) The subject having evident small intestinal bleeding.
5) The subjects having diverticula and diaphragm-like stenosis in the small intestine.
6) The subject who have renal and hepatic disfunction.
7) The subjects who has allergic hypersensitivity against rebamipide.
8) The subject who participate in other clinical studies within 4 weeks.
9) The subjects who are judged to be inappropriate for this study by doctors conducting the study.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuo Arakawa

Organization

Osaka City University Graduate School of Medicine

Division name

Gastroenterology

Zip code

Address

1-4-3 Asahi-machi, Abeno-ku, Osaka City

TEL

06-6645-3811

Email

ttanigawa@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshio Watanabe

Organization

Osaka City University Graduate School of Medicine

Division name

Gastroenterology

Zip code

Address

1-4-3 Asahi-machi, Abeno-ku, Osaka City

TEL

06-6645-3811

Homepage URL

Email

ttanigawa@med.osaka-cu.ac.jp

Institute

Osaka City University Graduate School of Medicine
Osaka Medical College
Kyoto Prefectural University of Medicine
Saga University

Institute

Department

Personal name

Organization

Osaka City University Graduate School of Medicine
Osaka Medical College
Kyoto Prefectural University of Medicine
Saga University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

04

Month

08

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2010

Year

01

Month

14

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

08

Day

Last modified on

2015

Year

08

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004171