UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001801 |
|---|---|
| Receipt number | R000002175 |
| Scientific Title | Adhesion of ecabet sodium in the form of enteric coated capsule to the surface of small intestine. |
| Date of disclosure of the study information | 2009/04/01 |
| Last modified on | 2010/02/15 19:12:37 |
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Basic information
Public title
Adhesion of ecabet sodium in the form of enteric coated capsule to the surface of small intestine.
Acronym
Ecabet sodium adhesion to small intestine
Scientific Title
Adhesion of ecabet sodium in the form of enteric coated capsule to the surface of small intestine.
Scientific Title:Acronym
Ecabet sodium adhesion to small intestine
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the adhesive ability of ecabet sodium in the form of enteric coated capsule to the surface of small intestinal mucosa by capsule endoscopy.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
To compare the adhesive ability of ecabet sodium in the form of enteric coated capsule with that in the form of conventional granules to small intestine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Granule form of ecabet sodium
Interventions/Control_2
Enteric coated capsule form of ecabet sodium
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers with informed consent
Key exclusion criteria
1. Organic disease(Reflux esophagitis, Peptic ulcer disease, Erosive gastritis)
2. Past history of GI resection surgery other than appendectomy.
3. Intestinal lesions such as Crohn's disease, Behcet disease.
4. Patients with pace maker or with other electric device in the body
5. NSAIDs user, Patients with severe stress conditions
6. Organic disease in brain, Depression and Schizophrenia
7. Alcoholics and Drug dependence
8. Hyperthyroidism
9. Severe heart, liver and kidney diseases or infectious diseases
10. Drug allergy for ecabet sodium
11. Expectant mother, Breast feeding mother
12. Drug (anti-secretory drugs, prokinetics, antacid, anti-cholinergic agents, tranquilizer, anti-depressant)users within a week before the entry.
13. Subjects recognized as not suitable to the test by doctor.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki, M.D., Ph.D. |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3914
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki, M.D., Ph.D. |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3914
Homepage URL
hsuzuki@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University 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
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
| 2009 | Year | 04 | Month | 01 | 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 | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 26 | Day |
Last modified on
| 2010 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002175
