UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003739 |
|---|---|
| Receipt number | R000003961 |
| Scientific Title | Clinical effects of ghrelin on gastrointestinal involvement in patients with systemic sclerosis |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2012/06/11 09:06:52 |
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Basic information
Public title
Clinical effects of ghrelin on gastrointestinal involvement in patients with systemic sclerosis
Acronym
Clinical effects of ghrelin on GI involvement in SSc
Scientific Title
Clinical effects of ghrelin on gastrointestinal involvement in patients with systemic sclerosis
Scientific Title:Acronym
Clinical effects of ghrelin on GI involvement in SSc
Region
| Japan |
Condition
Condition
systemic sclerosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate clinical effects and safety on gastrointestinal involvement in patients with systemic sclerosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tmax in 13C respiration test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment A-2 wks after-Treatment B
Interventions/Control_2
Treatment B-2 wks after-Treatment A
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Dx as SSc
2) Gastrointestinal involvement (+)
3) Informed consent (+)
Key exclusion criteria
1) localized scleroderma
2) dysphagia due to the stenosis of esophagus
3) Intravenous Hyperalimentation or tube feeding
4) past history of open-abdominal operation of GI tract
5) allergy against milk or Lacol
6) Severe hepato-renal or respiratory disorders, severe depression, schizophrenia, mania, severe diabetes, congenital amino acid metabolic disorder
7)tendency or past history of suicide
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akamizu |
Organization
Kyoto University Hospital
Division name
Translational research center
Zip code
Address
54, Syogoin-kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-4720
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Akamizu |
Organization
Kyoto University Hospital
Division name
Translational research center
Zip code
Address
Sakyo-ku, Kyoto
TEL
075-751-4720
Homepage URL
http://www.kuhp.kyoto-u.ac.jp/~ghrelin/index.html
akamizu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Translational research center, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Translational research center, Kyoto University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
京都大学医学部付属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.kuhp.kyoto-u.ac.jp/~ghrelin/index.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.kuhp.kyoto-u.ac.jp/~ghrelin/index.html
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
| 2010 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 11 | Day |
Last modified on
| 2012 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003961
