UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002112 |
|---|---|
| Receipt number | 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 18:05:12 |
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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
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
Sponsor or person
Institute
Department of Orthopaedic Surgery, Mie University Hospital
Department of Gastroenterology and Hepatology, Mie University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
