UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004271
Receipt number R000005122
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
Date of disclosure of the study information 2010/09/27
Last modified on 2010/09/27 20:39:50

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Basic information

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

Condition

Rheumatoid arthritis (RA)
NSAIDs-induced gastrointestinal mucosal injury

Classification by specialty

Gastroenterology Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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



Public contact

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



Sponsor or person

Institute

Hoshigaoka Koseinenkin Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


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

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


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 27 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name