UMIN-CTR Clinical Trial

Public title

Effect of rebamipide on anemia in patients under LDA or NSAIDs treatment
-exploratory research-

Acronym

Effect of rebamipide on anemia in patients under LDA or NSAIDs treatment

Scientific Title

Effect of rebamipide on anemia in patients under LDA or NSAIDs treatment
-exploratory research-

Scientific Title:Acronym

Effect of rebamipide on anemia in patients under LDA or NSAIDs treatment

Region

Japan

Condition

anemia induced by ulcers and /or erosions of small intestine

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Exploratory research of the effect of rebamipide (900mg/day) against the anemia patients under treatment with LDA and/or NSAIDs who are diagnosed as occult bleeding from small intestine.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

changes of hemoglobin by rebamipide treatment

Key secondary outcomes

Study type

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

rebamipide 900mg/day

Interventions/Control_2

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. Age: more than 20 years old. Regardless of sex.
2. Patients who were diagnosed as iron deficiency anemia and /or occult blood test of feces positive
3. Patients whose LDAs and/or NSAIDs and/or other anti-platelet agents doses were not changed in 3 months before informed consent acquisition.
4. Patients who were not detected any lesions speculated to be the cause of anemia in GIF and CF examination in 3 months before informed consent acquisition.
5. Patient whose informed consent was obtained in the documents.

Key exclusion criteria

1.Patients who were detected some bleeding lesions in GI tract.
2.Patients who were diagnosed as GI tract obstraction.
3.Patients with malignant neoplasia
4.Patients who were detected any tumors and /or diverticula as the origin of bleeding in small intestine.
5.Patients who were speculated to have bleeding from the diverticulum of colon.
6.Patinets of Crohn' s disease and/or UC.
7.Patients who were speculated to the bleeding from anywhere but GI tract.
8.Patient who received surgical operation in 3 months before study.
9.Patients whose medication were changed.
10.Patients who undergo dialysis.
11.Patients who have renal disturbance; serum creatinine, Scr>2 mg/dL.
12. Patients who need erythropoietin administration
13. Patients who were speculated to be iron uptake disturbance after gastrectomy
14. Patients who are decompensated liver cirrhosis
15. Patients who take sulfasalazine and/or misoprostole and/or antibiotics
16. Patients who are judged to be inappropriate for this clinical trial by attending physician.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiromi Kataoka

Organization

Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

Division name

Dept of Gastroenterology and Metabolism

Zip code

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya,

TEL

052-853-8211

Email

hkataoka@med.nagoya-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Kataoka H, Kubota E

Organization

Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

Division name

Dept of Gastroenterology and Metabolism

Zip code

Address

1 Kawasumi, Mizuho-cho, MIzuho-ku,

TEL

052-853-8211

Homepage URL

Email

hkataoka@med.nagoya-cu.ac.jp

Institute

Dept of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

Dept of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2013

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Terminated

Date of protocol fixation

2013

Year

04

Month

10

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

07

Day

Last follow-up date

2014

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

15

Day

Last modified on

2014

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012253