UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007936 |
|---|---|
| Receipt number | R000009345 |
| Scientific Title | Effects of 2-week celecoxib treatment on the small intestinal mucosa in Japanese healthy subjects evaluated by capsule endoscopy (A prospective, randomized, double-blind, parallel-group, controlled study compared to the combination of loxoprofen sodium and lansoprazole) |
| Date of disclosure of the study information | 2012/05/13 |
| Last modified on | 2013/03/15 21:42:08 |
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Basic information
Public title
Effects of 2-week celecoxib treatment on the small intestinal mucosa in Japanese healthy subjects evaluated by capsule endoscopy (A prospective, randomized, double-blind, parallel-group, controlled study compared to the combination of loxoprofen sodium and lansoprazole)
Acronym
Capsule endoscopy: Celecoxib vs Loxoprofen/ Lansoprazole
Scientific Title
Effects of 2-week celecoxib treatment on the small intestinal mucosa in Japanese healthy subjects evaluated by capsule endoscopy (A prospective, randomized, double-blind, parallel-group, controlled study compared to the combination of loxoprofen sodium and lansoprazole)
Scientific Title:Acronym
Capsule endoscopy: Celecoxib vs Loxoprofen/ Lansoprazole
Region
| Japan |
Condition
Condition
NSAID-induced small-intestinal injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare the incidence rate of small intestinal mucosal injuries in healthy Japanese adults between celecoxib 100 mg twice daily and loxoprofen 60 mg three times daily plus lansoprazole 15 mg once daily by capsule endoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of small intestinal mucosal breaks evaluated by capsule
endoscopy after 2-week study treatment
Key secondary outcomes
1) The mean number of small bowel mucosal breaks per subject
2) Comparison of hemoglobin value and fecal occult blood reaction
3) Incidence rate of adverse events of the digestive system
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects in celecoxib group are administrated celecoxib 100 mg twice per day for 2 weeks
Interventions/Control_2
Subjects in loxoprofen + lansoprazole group are administrated loxoprofen 60 mg three times per day plus lansoprazole 15 mg once per day for 2 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy male and female adult Japanese volunteer
2) If the subject is female of childbearing potential, she must have been non-pregnant (negative pregnancy test at screening), non-lactating and using adequate contraception during the study
3) Clinical laboratory test results must have been normal or non-clinically significant at Pretreatment
4) Written informed consent must have been obtained
Key exclusion criteria
1) Positive in fecal occult blood test. Suspected gastrointestinal tract disturbance based on clinical safety laboratory tests and physical examination at screening
2) A possibility to effect on absorption of drugs (gastrectomy etc.)
3) A history of gastrointestinal ulcer
4) A history of gastrointestinal disease within 1 month or current gastrointestinal complaints at the time of admission to the study
5) Any use of celecoxib, nonsteroidal anti-inflammatory drugs, anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication.
6) A history of medically significant disease, including ischemic heart disease
7) Subject has a serious hematological abnormality or serious cardiac failure
8) Subject has an active malignancy or history of a malignancy within 5 years prior to enrollment in study.
9) A history of chronic ingestion of more than 2 alcoholic drinks per day (1 drink: wine 150 mL, beer 360 mL or spirit 45 mL)
10) Clinically significant abnormalities in 12-lead ECG
11)Hypersensitivity to celecoxib, sulfonamides, aspirin, NSAIDs, or lansoprazole
12) A history of aspirin- or NSAIDs-induced asthma
13)Laboratory screening >1.5 ULN for AST, ALT, serum creatinine more than 1.1 mg/dL or other clinically significant lab abnormalities at screening
14) Positive in HBs antigen tests, HIV test, HCV test and syphilis test at screening
15) Positive in urine drug test at screening
16) Judged to be inappropriate due to psychiatric disorders
17) Received any investigational drug within 30 days
18) Other serious acute/chronic medical/psychological condition, and other laboratory abnormalities that may be worsened by the trial or test drug administration, or that may affect the trial endpoints
19) Any other subjects judged to be inappropriate to participate in the study by the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Choitsu Sakamoto |
Organization
Nippon Medical School
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Fujimori |
Organization
Nippon Medical School
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603
TEL
Homepage URL
Sponsor or person
Institute
Division of gastroenterology, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sumida Hospital
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
医療法人相生会 墨田病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 13 | 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
| 2012 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 13 | Day |
Last modified on
| 2013 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009345
