UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021368
Receipt number 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 10:18:18

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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 or person

Institute

Keieikai Yashio Hospital

Institute

Department

Personal name



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

Value
https://center6.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