UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003871 |
|---|---|
| Receipt number | R000004659 |
| Scientific Title | Prospective, randomized, double-blind, controlled study for the incidence of small bowel mucosal injury caused by selective COX-2 inhibitor in healthy volunteers |
| Date of disclosure of the study information | 2010/07/05 |
| Last modified on | 2011/07/13 22:29:32 |
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Basic information
Public title
Prospective, randomized, double-blind, controlled study for the incidence of small bowel mucosal injury caused by selective COX-2 inhibitor in healthy volunteers
Acronym
Clinical trial for the incidence of small bowel mucosal injury by selective COX-2 inhibitor
Scientific Title
Prospective, randomized, double-blind, controlled study for the incidence of small bowel mucosal injury caused by selective COX-2 inhibitor in healthy volunteers
Scientific Title:Acronym
Clinical trial for the incidence of small bowel mucosal injury by selective COX-2 inhibitor
Region
| Japan |
Condition
Condition
Small bowel mucosal injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to ascertain the superiority of celecoxib, a selective COX-2 inhibitor, for the small bowel mucosal injury in comparison to meloxicam, a NSAID with preferential COX-2 inhibition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number and incidence of small bowel pathologies (ulcer, hemorrhage and mucosal break) under capsule endoscopy after 2 weeks medication.
Key secondary outcomes
Abdominal symptoms and laboratory data including anemia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects in celecoxib group are administered celecoxib 200mg twice per day for two weeks.
Interventions/Control_2
Subjects in meloxicam group are administered meloxicam 10mg once per day for two weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers obtained written informed consent
Key exclusion criteria
1) Subjects with a history of peptic ulcers
2) Subjects treated by corticosteroid (>10mg of prednisolone)
3) Subjects treated continuously with NSAIDs
4) Subjects treated with aspirin
5) Subjects with a history of aspirin-induced asthma
6) Subjects allergic to sulufonamids
7) Subjects treated with anti-ulcer drugs (misoprostol, rebamipide, teprenone, etc)
8) Subjects with stenosis of gastrointestinal tract or severe adhesion
9) Subjects with malignancy, psychosis, severe hepatic, renal dysfunction, heart disease, or hematologic disease
10) Pregnant and nursing women
11) Subjects with other disorders who are judged as inappropriate for the participation of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Esaki, Yuji Maehata |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Homepage URL
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukuoka Sanno Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
FS-2-0903-049
Org. issuing International ID_1
International university of health and welfare graduate school
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 05 | 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 | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 05 | Day |
Last modified on
| 2011 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004659
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