UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000021318 |
| Receipt No. | 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 (Ver. 9) |
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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 |
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| Condition | ||
| Condition | dermal pruritus | |
| Classification by specialty |
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| 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 |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 33 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Shimane University Hospital | ||||||
| Division name | Dermatology | ||||||
| Zip code | 6938501 | ||||||
| Address | Enya 89-1 Izumo Shimane 693-8501 Japan | ||||||
| TEL | 0853-20-2210 | ||||||
| kanekos2@med.shimane-u.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| 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 | |||||||
| kanekos2@med.shimane-u.ac.jp | |||||||
| Sponsor | |
| Institute | Department of Dermatology Faculty of Medicine Shimane University |
| Institute | |
| Department | |
| 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 |
| 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 |
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| 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 |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021 |
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| Participant flow | https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021 |
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| Adverse events | https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021 |
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| Outcome measures | https://onlinelibrary.wiley.com/doi/epdf/10.1002/cia2.12021 |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023942 |
