UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001264
Receipt No. R000001539
Scientific Title Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers
Date of disclosure of the study information 2008/07/24
Last modified on 2008/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers
Acronym Incidence of small bowel injury induced by low-dose aspirin
Scientific Title Clinical trial on the incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers
Scientific Title:Acronym Incidence of small bowel injury induced by low-dose aspirin
Region
Japan

Condition
Condition Small bowel mucosal injury
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the incidence of small bowel injury in healthy volunteers treated with short-term low-dose aspirin using capsule endoscopy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of capsule endoscopic findings (red spots, loss of villi, mucosal breaks)
Key secondary outcomes Symptom assessment (abdominal pain, diarrhea, melena)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Enteric-coated aspirin 100 mg/day for 14 days - (washout period of at least 4 weeks) - no drug for 14 days
Interventions/Control_2 No drug for 14 days - (washout period of at least 4 weeks) - enteric-coated aspirin 100 mg/day for 14 days
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
Key inclusion criteria a. Healthy male subjects who have a normal physical examination and laboratory results
b. Obtaining informed consent
Key exclusion criteria a. Subjects taken NSAID or aspirin within the last 3 months
b. Allergic or idiosyncratic to the drug
c. Useage of antiulcer medication (H2RA, PPI or misoprostol)
d. Chronic alcohol consumption
e. A history of abdominal surgery
f. Serious central nervous system
g. Psychiatric diseases
h. Cardiovascular diseases
i. Respiratory diseases
j. Gastrointestinal diseases
k. The subject of any other clinical test/trial which will affect the results this study
l. Can not comply with the study requirements or cannot follow instructions for the device
m. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred
o. Inadequate to entry judged by investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
Homepage URL
Email

Sponsor
Institute Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 24 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
2008 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 23 Day
Last modified on
2008 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.