UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030534 |
|---|---|
| Receipt number | R000034859 |
| Scientific Title | The Effect of Trimebutine Maleate in Capsule Enteroscopy |
| Date of disclosure of the study information | 2017/12/23 |
| Last modified on | 2019/12/29 13:35:55 |
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Basic information
Public title
The Effect of Trimebutine Maleate in Capsule Enteroscopy
Acronym
The Effect of Trimebutine Maleate in Capsule Enteroscopy
Scientific Title
The Effect of Trimebutine Maleate in Capsule Enteroscopy
Scientific Title:Acronym
The Effect of Trimebutine Maleate in Capsule Enteroscopy
Region
| Japan |
Condition
Condition
small bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of trimebutine maleate on gastrointestinal transit time and diagnostic yield of capsule endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal transit time of capsule endoscopy.
Key secondary outcomes
diagnostic yield of capsule endoscopy.
Field of clearly view in the gastrointestinal tract.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
the trimebutine maleate group
Interventions/Control_2
the control group
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent CE
patients who had Chronic gastritis or Irritable bowel syndrome
Key exclusion criteria
Severe liver dysfunction,
pregnancy,
Patients taking of trimebutine maleate at registration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Nishiyama |
Organization
Hiratsuka kyosai hospital
Division name
Department of Gastroenterology
Zip code
2548502
Address
Oiwake9-11,Hiratsuka-shi,Kanagawa,Japan
TEL
0463-32-1950
ryuwest@jcom.zaq.ne.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Nishiyama |
Organization
Hiratsuka kyosai hospital
Division name
Department of Gastroenterology
Zip code
2548502
Address
Oiwake9-11,Hiratsuka-shi,Kanagawa,Japan
TEL
0463-32-1950
Homepage URL
ryuwest@jcom.zaq.ne.jp
Sponsor or person
Institute
Hiratsuka kyosai hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Hiratsuka kyosai hospital
Department of Gastroenterology
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
Hiratsuka kyosai hospital IRB
Address
Oiwake9-11,Hiratsuka-shi,Kanagawa,Japan
Tel
0463-32-1950
ryuwest@jcom.zaq.ne.jp
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
国家公務員共済組合連合会 平塚共済病院(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034859
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
