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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007936
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Division of gastroenterology, Nippon Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009345

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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