UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010609 |
|---|---|
| Receipt number | R000012404 |
| Scientific Title | Evaluation of utility and safety of new laxative (Moviprep) for preparation of colonoscopy in patients with inflammatory bowel diseases |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2019/03/20 18:54:09 |
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Basic information
Public title
Evaluation of utility and safety of new laxative (Moviprep) for preparation of colonoscopy in patients with inflammatory bowel diseases
Acronym
Evaluation of new laxative in IBD patients
Scientific Title
Evaluation of utility and safety of new laxative (Moviprep) for preparation of colonoscopy in patients with inflammatory bowel diseases
Scientific Title:Acronym
Evaluation of new laxative in IBD patients
Region
| Japan |
Condition
Condition
inflammatory bowel diseases
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of utility and safety of new laxative (Moviprep) for patients with inflammatory bowel diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clensing effects of laxatives
Key secondary outcomes
Persentage of patients who underwent colonoscopy
Dose and time of laxatives for the preparation of colonoscopy
Changes of body weight
Blood chemistry and urine examination
Clinical activity after colonoscopy
Capability of using laxatives
Adverse enents
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
patients who take Moviprep
Interventions/Control_2
patients who take Niflec
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
IBD patients who undergo colonoscopy or transanal balloon enteroscopy
IBD patients who can take laxative
IBD patients who has wtitten informed consent form
IBD patinets whose age are over 17 years old
Key exclusion criteria
Patients who has obstruction and/or suspicious obstruction of gastorointestinal tract
Patients who has perforation and/or suspicious perforation ofgastorointestinal tract
Patients who has delayed exhaust in stomach
Patients with toxic megacolon
Patients who has allergy of laxatives
Patinets who are determiend not to be appropriate for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of gastroenterology and hepatology
Zip code
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of gastroenterology and hepatology
Zip code
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
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
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012404
