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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021368
Receipt No. R000024642
Scientific Title An open trial of polaprezinc for binge eating
Date of disclosure of the study information 2016/03/06
Last modified on 2019/05/31

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Basic information
Public title An open trial of polaprezinc for binge eating
Acronym An open trial of polaprezinc for binge eating
Scientific Title An open trial of polaprezinc for binge eating
Scientific Title:Acronym An open trial of polaprezinc for binge eating
Region
Japan

Condition
Condition Bulimia nervosa
Binge-eating disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of polaprezinc in patients with binge eating.
To examine the changes in plasma concentrations of brain-derived neurotrophic factor (BDNF) before and after polaprezinc treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of binge eating
[at baseline and at 4, 8, 12, and 16 weeks after intervention]
Key secondary outcomes EDE-Q
QIDS-SR16
Body weight
Biochemistry
[at baseline and at 4, 8, 12, and 16 weeks after intervention]
Plasma concentrations of BDNF
[at baseline and at 16 weeks after intervention (or endpoint of study)]

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Polaprezinc 75 or 150 mg/day per os for 16 weeks.
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Currently meets DSM-V criteria for bulimia nervosa or binge-eating disorder despite receiving antidepressant treatment for at least 8 weeks; and
2. Is able to provide written informed consent.
Key exclusion criteria 1. Has a history of a personality disorder that may interfere with assessment or adherence to study procedures;
2. Is at serious suicidal risk;
3. Has a clinically unstable medical illness;
4. Is pregnant, planning on becoming pregnant during the study period, or lactating;
5. Receiving cognitive-behavioral or interpersonal therapy; and
6. Has received polaprezinc in the past 6 months.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Kensaku
Middle name
Last name Sakae
Organization Keieikai Yashio Hospital
Division name Department of psychiatry
Zip code 340-0802
Address 1089 Tsurugasone, Yashio-shi, Saitama 340-0802, Japan
TEL 048-996-3034
Email yashiohp@nifty.com

Public contact
Name of contact person
1st name Kensaku
Middle name
Last name Sakae
Organization Keieikai Yashio Hospital
Division name Department of psychiatry
Zip code 340-0802
Address 1089 Tsurugasone, Yashio-shi, Saitama 340-0802, Japan
TEL 048-996-3034
Homepage URL
Email yashiohp@nifty.com

Sponsor
Institute Keieikai Yashio Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of the Jikei University School of Medicine
Address 3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel 03-3433-1111(ext.2134)
Email rinri@jikei.ac.jp

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 医療法人慶榮会 八潮病院(埼玉県)
医療法人慶榮会 友愛クリニック(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 06 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 Completed
Date of protocol fixation
2016 Year 02 Month 29 Day
Date of IRB
2016 Year 02 Month 29 Day
Anticipated trial start date
2016 Year 03 Month 07 Day
Last follow-up date
2019 Year 02 Month 23 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 03 Month 06 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024642

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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