JRCT ID: jRCT2080221375
Registered date:08/02/2011
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Pruritus associated with atopic dermatitis |
Date of first enrollment | 08/02/2011 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : NST-141 ointment 1% INN of investigational material : Therapeutic category code : 264 Analgesics, anti-itchings, astrigents and anti-inflammatory agents Dosage and Administration for Investigational material : External use control material(s) Generic name etc : NST-141 ointment (placebo) INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : External use |
Outcome(s)
Primary Outcome | Change in levels of pruritus |
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Secondary Outcome | Pruritus score |
Key inclusion & exclusion criteria
Age minimum | >= 16age old |
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Age maximum | <= 64age old |
Gender | Both |
Include criteria | (1) Signed, written informed consent. (2) Able to be treated as an outpatient. (3) Diagnosis of atopic dermatitis by Japanese dermatological association criteria. |
Exclude criteria | (1) Serious asthma. (2) Hepatic, renal, heart or hematological disease considered to be clinically significant by the Investigator's opinion. (3) Infection of skin with antimicrobial use. |
Related Information
Primary Sponsor | TAIHO PHARMACEUTICAL CO.,LTD, NIPPON SHINYAKU CO.,LTD |
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Secondary Sponsor | |
Source(s) of Monetary Support | Taiho Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd. |
Secondary ID(s) | JapicCTI-111414 |
Contact
Public contact | |
Name | |
Address | kouhou@mb.nippon-shinyaku.co.jp |
Telephone | |
Affiliation | Nippon Shinyaku,.Co. Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |