UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003890 |
|---|---|
| Receipt number | R000004684 |
| Scientific Title | Gastroparesis during pegylated interferon therapy for chronic hepatitis C: Effects of mosapride |
| Date of disclosure of the study information | 2010/07/09 |
| Last modified on | 2010/07/08 19:01:19 |
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Basic information
Public title
Gastroparesis during pegylated interferon therapy for chronic hepatitis C: Effects of mosapride
Acronym
Effects of mosapride for interferon gastroparesis
Scientific Title
Gastroparesis during pegylated interferon therapy for chronic hepatitis C: Effects of mosapride
Scientific Title:Acronym
Effects of mosapride for interferon gastroparesis
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate mosapride effect on interferon gastroparesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total gastric T1/2, proximal gastric T1/2, distal gastric T1/2, and digestive symptoms scored at the time of gastric emptying scintigraphy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mosapride group: pegylated (Peg) interferon (IFN) (Pegintron; Schering-Plough Co., Inc., NJ, USA) 60-100 microgram per week and 5 miri gram of mosapride citrate (Gasmotin; Dainippon Sumitomo Pharma Co., Inc., Tokyo, Japan) orally three times daily
Interventions/Control_2
Control group: PegIFN 60-100 microgram per week with no mosapride citrate
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
| 25 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
histologically confirmed chronic active hepatitis, presence of hepatitis C virus (HCV) RNA
Key exclusion criteria
presence of gastrointestinal disease and history of gastric surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Shiomi |
Organization
Graduate School of Medicine, Osaka City University
Division name
Dept. of nuclear medicine
Zip code
Address
1-4-3 Asahimachi, Abenoku, Osaka 545-8585, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsushi Kawamura |
Organization
Graduate School of Medicine, Osaka City University
Division name
Dept. of nuclear medicine
Zip code
Address
TEL
Homepage URL
etsushi-k@med.osaka-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Osaka City 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
| 2010 | Year | 07 | 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
| 2005 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 08 | Day |
Last modified on
| 2010 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004684
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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