UMIN-CTR Clinical Trial

Public title

Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).

Acronym

Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.

Scientific Title

Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).

Scientific Title:Acronym

Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.

Region

Japan

Condition

Patients with rheumatoid arthritis with anemia taking NSAIDs

Classification by specialty

Gastroenterology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the efficacy of mesalazine for the treatment of intestinal injury caused by NSAIDs

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Endoscopic findings by capsule endoscopy.
Side effects due to the mesalazine treatment.

Key secondary outcomes

Patients' joint and abdominal symptoms. Serum cytokines. Fecal calprotectin

Study type

Interventional

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

Treatment with mesalazine

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

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Rheumatoid arthritis patients aged older than 20y and younger than 70 y who were taking NSAIDs for more than 3 mo and will take NSAIDs for the additional 8 w.
2)The patients with anemia (Hg levels lower than 13.8 g/dl (men) 12.0 g/dl(women) and without abnormalities in the liver and renal function tests.

Key exclusion criteria

Patients treated with mesalazine or salicylic acid 2 weeks proior to the entry of this study.
Patients with escalating the dose of anti-rheumatoid arthritis drugs such as aspirins or proton pump inhitors.
Patients took gastroprotective agents such as rebamipide, ecabet sodium, misoprostol.
Patients being treated with high-dose corticosteroids (more than 15 mg/day of prednisolone.
Patients treated with biologics 90 days prior to the entry of this study.
Patients who were allergic to or suffered from side effects by mesalazine of salicylic acids.
Patients incapable of swallowing capsule endoscopy.
Patients suspicious of intestinal strictures.
Patients with malignancies.
Pregnancy or possible pregnancy.
Patients with side effects by other previous clinical studies.
Patients who were considered unsuitable for this study by doctors.

Target sample size

13

Name of lead principal investigator

1st name
Middle name
Last name	Hideki Iijima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicin

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

TEL

Homepage URL

Email

hiijima@gh.med.osaka-u.ac.jp

Institute

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

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

2011

Year

04

Month

01

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

Completed

Date of protocol fixation

2011

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

04

Month

01

Day

Last follow-up date

2012

Year

11

Month

30

Day

Date of closure to data entry

2012

Year

11

Month

30

Day

Date trial data considered complete

2013

Year

03

Month

28

Day

Date analysis concluded

2013

Year

03

Month

28

Day

Other related information

Registered date

2011

Year

04

Month

01

Day

Last modified on

2013

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006363