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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003739
Receipt No. 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

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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
Email

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
Email akamizu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Translational research center, Kyoto University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003961

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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