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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003871
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004659

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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