UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022879 |
|---|---|
| Receipt number | R000026367 |
| Scientific Title | Interventional study for severe obesity patients with non-alcoholic fatty liver disease (NAFLD) by Mazindol |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2018/06/26 10:07:17 |
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Basic information
Public title
Interventional study for severe obesity patients with
non-alcoholic fatty liver disease (NAFLD) by Mazindol
Acronym
Interventional study for severe obesity with NAFLD by Mazindol
Scientific Title
Interventional study for severe obesity patients with
non-alcoholic fatty liver disease (NAFLD) by Mazindol
Scientific Title:Acronym
Interventional study for severe obesity with NAFLD by Mazindol
Region
| Japan |
Condition
Condition
Severe obesity patient with non-alcoholic fatty liver disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze the effect of Mazindol on NAFLD in severe obesity patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in body weight 12 weeks after administration
Key secondary outcomes
Improvement in liver function 12 weeks after administration
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
12 weeks, Mazindol 1.5 mg/day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with BMI above 35 and NAFLD diagnosed with the NAFLD guideline 2010
Key exclusion criteria
Allergy to Mazindol, Glaucoma, Severe heart disease, Severe diabetes mellitus, Severe liver and renal disturbance, Severe hypertension, Cerebrovascular disease, Mental illness, Seizure, Alcohol and drug abuse, MAO inhibitor, Pregnant woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsurou Satoh |
Organization
Gunma University Hospital
Division name
Endocrinolgy and Diabetes
Zip code
Address
3-39-15 Showa-machi, Maebashi
TEL
027-220-8122
tsato@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyo Nakajima |
Organization
Gunma University Hospital
Division name
Endocrinology and Diabates
Zip code
Address
3-39-15 Showa-machi, Maebashi
TEL
027-220-8122
Homepage URL
ynihei@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
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
| 2016 | Year | 07 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026367
