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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030933
Receipt No. R000034580
Scientific Title Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides
Date of disclosure of the study information 2018/12/01
Last modified on 2018/05/21

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Basic information
Public title Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides
Acronym Pleiotropic effects of mazindol
Scientific Title Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides
Scientific Title:Acronym Pleiotropic effects of mazindol
Region
Japan

Condition
Condition Obesity diseases
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the action of mazindol on obesity-related factors such as incretin, adipocytokines, FGF19, and FGF21, which has attracted attention in recent years.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of body weight and body composition before and after 3 month use of mazindol, and the differences of body weight and body composition using or not using mazindol
Key secondary outcomes 1)Insulin, incretin, glucagon, gastrointestinal peptide,FGF19, FGF21 secretion capacity and pattern by glucagon tolerance test
2)Changes in urine glucose, urine protein, adipocytokines, hs-CRP, uric acid, basal metabolism, blood pressure, blood pressure pulse wave examination before and after use of mazindol

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In the mazindol administration group, mazindol is gradually increased from 0.5 mg/day to 1.5 mg/day and administered for 3 months after 3 to 6 months from the start of the test.
Interventions/Control_2 In the regular treatment group, Mazindol do not be use but continue meal, exercise, behavioral therapy.
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
70 years-old >
Gender Male and Female
Key inclusion criteria The patients aged 20 to 70 years old with obesity disease. BMI is 35 or more.
Key exclusion criteria 1.Patient who cannnot regulary visit h ospital
2.Patients with anxiety / depression / abnormal excitement or patients with psychiatric disorders such as schizophrenia
3. Patient who judged inappropriate due to the complications and treatment by attending doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ueno
Organization University of Miyazaki , fuculty of med icine
Division name Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miya zaki, Japan
TEL 0985-85-2695
Email intron@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ueno
Organization University of Miyazaki , fuculty of med icine
Division name Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine,
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miya zaki, Japan
TEL 0985-85-2695
Homepage URL
Email intron@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki , fuculty of med icine, Neurology, Respirology, Endocri nology and Metabolism, Department o f Internal Medicine
Institute
Department

Funding Source
Organization FUJIFILM Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 宮崎大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 12 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
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 22 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034580

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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