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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002112
Receipt No. R000002562
Scientific Title Healing Effect of Gastric mucosal Lesion of patient with Osteoarthritis or Rheumatism by Cox2-Inhibitor and Anti ulcer agent(Rebamipide) combination therapy.
Date of disclosure of the study information 2009/07/01
Last modified on 2011/06/17

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Basic information
Public title Healing Effect of Gastric mucosal Lesion of patient with Osteoarthritis or Rheumatism by Cox2-Inhibitor and Anti ulcer agent(Rebamipide) combination therapy.
Acronym GLORIA
Scientific Title Healing Effect of Gastric mucosal Lesion of patient with Osteoarthritis or Rheumatism by Cox2-Inhibitor and Anti ulcer agent(Rebamipide) combination therapy.
Scientific Title:Acronym GLORIA
Region
Japan

Condition
Condition rheumatic arthritis
osteoarthritis
lumbago
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The comparison of frequency of the gastrointestinal disorder in the group of celecoxib single administration and the group of the combined administration of celecoxib and rebamipide.
And reserch of the factors that influence it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes An incidence of gastrointestinal bleeding or endoscopic ulcer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Administration of celecoxib
Interventions/Control_2 Combined administration of celecoxib and rebamipide
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 rheumatic arthritis
osteoarthritis
lumbago

Patient who have either the above-mentioned disease and gave prior written informed consent.
Key exclusion criteria History of gastrointestinal surgery
Presence of gastroesophageal reflex disease (GERD)
Presence of malignancy
Presence of gastrointestinal bleeding or gastrointestinal ulcer
Presence of aspirin-induced asthma
Pcesence of severe cardiac disorder, renal disorder or liver disorder
Impossibility of endoscopic examination
Presence of allergy of celecoxib or rebamipide
History of percutaneous coronary revascularization
Pregnancy and lactation
Impossibility of discontinuation of proton pump inhibitor or histamine-2 receptor antagonist
Administration of NSAID that excludes aspirin
Patient who doctor judged improper
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hasegawa
Organization Mie University Hospital
Division name Orthopaedic Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie Japan
TEL 059-232-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyosuke Tanaka
Organization Mie University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Orthopaedic Surgery, Mie University Hospital
Department of Gastroenterology and Hepatology, Mie University Hospital
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery, Mie University Hospital
Department of Gastroenterology and Hepatology, Mie University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 01 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
2009 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 23 Day
Last modified on
2011 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002562

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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