UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012518 |
|---|---|
| Receipt number | R000014516 |
| Scientific Title | Study of efficacy and tolerability of combination therapy with low-volume polyethylene glycol (Moviprep), sodium picosulfate hydrate (pursennid), mosapride citrate hydrate (gasmotin) on bowel preparation. |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2015/12/08 12:24:12 |
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Basic information
Public title
Study of efficacy and tolerability of combination therapy with low-volume polyethylene glycol (Moviprep), sodium picosulfate hydrate (pursennid), mosapride citrate hydrate (gasmotin) on bowel preparation.
Acronym
Study of efficacy and tolerability of combination therapy with low-volume polyethylene glycol (Moviprep), sodium picosulfate hydrate (pursennid), mosapride citrate hydrate (gasmotin) on bowel preparation.
Scientific Title
Study of efficacy and tolerability of combination therapy with low-volume polyethylene glycol (Moviprep), sodium picosulfate hydrate (pursennid), mosapride citrate hydrate (gasmotin) on bowel preparation.
Scientific Title:Acronym
Study of efficacy and tolerability of combination therapy with low-volume polyethylene glycol (Moviprep), sodium picosulfate hydrate (pursennid), mosapride citrate hydrate (gasmotin) on bowel preparation.
Region
| Japan |
Condition
Condition
Bowel preparation for colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and tolerability and safety of low-dose moviprep in combination with pursennid and gasmotin on bowel preparation.
Evaluation of tolerability of Moviprep versus standard polyethylene glycol solution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel cleansing level on colonoscopy
Key secondary outcomes
Evaluation of colonoscopic performer
-bowel cleaning level
-time to completion of bowel cleansing
- smoothness of the scope
Safety and tolerability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Bowel preparation with moviprep in combination with pursennid and gasmotin.
Interventions/Control_2
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Out or inpatients who underwent colonoscopy in our hospital.
2.Patients provided a written informed consent.
Key exclusion criteria
1.Patients who has obstruction and/or suspicious obstruction of gastrointestinal tract
2.Patients who has intestinal perforation
3.Patients who has delayed exhaust in stomach
4.Patients with toxic megacolon.
5. Patients 65 years of age or older
6. Patients with aphasia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5802-1058
tomoyosi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5802-1058
Homepage URL
tomoyosi@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2013 | Year | 12 | Month | 09 | 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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 08 | Day |
Last modified on
| 2015 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014516
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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