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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004271
Receipt No. 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

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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
Institute Hoshigaoka Koseinenkin Hospital
Institute
Department

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
URL(English) https://upload.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


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