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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003890
Receipt No. 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

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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
Email

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
Email etsushi-k@med.osaka-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Osaka City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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