UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides
Title of the study (Brief title)	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	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
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	Hiroaki Ueno
Organization	University of Miyazaki , fuculty of med icine
Division name	Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine,
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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