UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021318
Receipt number R000023942
Scientific Title Study on antipruritic action of Neurotropin injection in humectant and antihistamine drug treatment-resistant patients with dermal pruritus
Date of disclosure of the study information 2016/03/03
Last modified on 2019/03/19 08:58:06

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Basic information

Public title

Study on antipruritic action of Neurotropin injection in humectant and antihistamine drug treatment-resistant patients with dermal pruritus

Acronym

Study on antipruritic action of Neurotropin injection

Scientific Title

Study on antipruritic action of Neurotropin injection in humectant and antihistamine drug treatment-resistant patients with dermal pruritus

Scientific Title:Acronym

Study on antipruritic action of Neurotropin injection

Region

Japan


Condition

Condition

dermal pruritus

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of Neurotropin injection for dermal pruritus

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sift of Shiratori's grade in pruritus severity during 7 weeks' intervention

Key secondary outcomes



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

Study on antipruritic action of Neurotropin injection in humectant and antihistamine drug treatment-resistant patients with dermal pruritus
Before a week, eight week treatment

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

1)Pruritis patient
2)Over 20-years-old
3)treatment of pruritis over a week
4)pruritic grade 2>=
5)agreement for this study
6)possible writing of pruritic daily

Key exclusion criteria

1)allergy for Neurotropin
2)other effective drug treatment for pruritis
3)patient of feed, pregnancy, or possible of pregnancy
4)impossible regularly consultation
5)heavy disease of heart, liver, or kidney
6)ohter impossible patient

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Sakae
Middle name
Last name Kaneko

Organization

Shimane University Hospital

Division name

Dermatology

Zip code

6938501

Address

Enya 89-1 Izumo Shimane 693-8501 Japan

TEL

0853-20-2210

Email

kanekos2@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Sakae
Middle name
Last name Kaneko

Organization

Shimane University Hospital

Division name

Dermatology

Zip code

6938501

Address

Enya 89-1 Izumo Shimane 693-8501 Japan01, Japan

TEL

0853-20-2210

Homepage URL


Email

kanekos2@med.shimane-u.ac.jp


Sponsor or person

Institute

Department of Dermatology Faculty of Medicine Shimane University

Institute

Department

Personal name



Funding Source

Organization

Research center for prevention of lifestyle-related disease

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Dean of Faculty of Medicine, Shimane University

Address

enya-cho 89-1, Izumo city

Tel

0853-20-2515

Email

mga-kikaku@office.shimane-u.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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 03 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Number of participants that the trial has enrolled

40

Results

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Results date posted

2019 Year 03 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Participant flow

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Adverse events

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Outcome measures

https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 03 Month 03 Day

Date of IRB

2015 Year 12 Month 21 Day

Anticipated trial start date

2016 Year 03 Month 04 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete

2017 Year 12 Month 01 Day

Date analysis concluded

2017 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2019 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023942


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name