UMIN-CTR Clinical Trial

Public title

Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib

Acronym

The usefulness of switching to celecoxib in patients with NSAIDs-induced gastrointestinal mucosal injury

Scientific Title

Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib

Scientific Title:Acronym

The usefulness of switching to celecoxib in patients with NSAIDs-induced gastrointestinal mucosal injury

Region

Japan

Condition

Rheumatoid arthritis (RA)
NSAIDs-induced gastrointestinal mucosal injury

Classification by specialty

Gastroenterology	Clinical immunology	Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

NSAIDs are widely used for pain relief in patients with RA, but use of NSAIDs is limited by gastrointestinal (GI) adverse effects. Selective COX-2 inhibitors such as celecoxib (CEL) have been proven to be less associated with GI complications than traditional NSAIDs. However, the effects of COX-2 inhibitors on the GI tract have not been well examined in patients with pre-existing NSAIDs-induced GI complications. The aim of this study is to investigate the usefulness of CEL administration after switching from NSAIDs in Japanese rheumatic patients with endoscopically identified GI mucosal injury after long-term use of NSAIDs.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Changes in incidence of gastroduodenal mucosal injury.

Key secondary outcomes

Incidence of gastroduodenal mucosal injury in patients with long-term NSAIDs therapy

Changes in disease activity measures of rheumatoid arthritis after switching to celecoxib

Adverse side effect

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

Japanese rheumatic patients who have been treated with NSAIDs for twelve or more weeks are switched to CEL (400mg/day). Upper GI endoscopy is conducted before and after administration of CEL. Patients with ulcers at the enrollment are switched to CEL (400mg/day) with famotidine (20mg/day) after healing of their pre-existing ulcers following treatment.

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. RA patients receiving traditional NSAIDs for twelve or more month
2. Patients of 20 years or more regardless of their gender, or being outpatients or not
3. Patients giving informed consent

Key exclusion criteria

Patients with
1. Gastrectomy or vagotomy
2. Malignancy
3. Severe hepatic dysfunction
4. Severe renal dysfunction
5. Severe cardiac dysfunction
6. hematologic disease

7. Patients showing hypersensitive reaction to celecoxib or one member of the sulfonamide class
8. Patients being pregnant or plan to become pregnant during treatment
9. Patients who are regarded as inadequate subject by physician in charge

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Shigeyoshi Tsuji

Organization

Hoshigaoka Koseinenkin Hospital

Division name

Department of Orthopaedic Surgery

Zip code

Address

4-8-1 Hoshigaoka Hirakata city Osaka 573-8511 Japan

TEL

072-840-2641

Email

Name of contact person

1st name
Middle name
Last name	Yoko Amino

Organization

Hoshigaoka Koseinenkin Hospital

Division name

Dept. of Clinical Trial Management

Zip code

Address

4-8-1 Hoshigaoka Hirakata city Osaka 573-8511 Japan

TEL

072-840-2641

Homepage URL

Email

Institute

Hoshigaoka Koseinenkin Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

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

星ヶ丘厚生年金病院（大阪府） Hoshigaoka Koseinenkin Hospital(Osaka)

Date of disclosure of the study information

2010

Year

09

Month

27

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

2008

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

04

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

09

Month

27

Day

Last modified on

2010

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005122