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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000029324 |
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Date of registration:
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01/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis
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Scientific title:
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Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis - Clinical trial of thalidomide for CGD colitis |
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Date of first enrolment:
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2017/09/28 |
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Target sample size:
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8 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033119 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Mayumi
Sako |
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Address:
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2-10-1 Okura, Setagaya-ku, Tokyo, Japan
157-8535
Japan |
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Telephone:
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03-3416-0181 |
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Email:
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sako-m@ncchd.go.jp |
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Affiliation:
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National Center for Child Heath and Development Division of Child Health and Development |
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Name:
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Toshinao
Kawai |
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Address:
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2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3416-0181 |
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Email:
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kawai-t@ncchd.go.jp |
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Affiliation:
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National Center for Child Heath and Development Division of Immunology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients allergic to the drug ingredients 2) Patients with HIV infection 3) Cancer except granuloma 4) Macrophage activating syndrome 5) Any mental problem 6) Pregnant or breast-feeding woman 7) Taking thalidomide or having a history of thalidomide administration 8) Oral, intravenous, or enema administration of steroid within four weeks of providing informed consent 9) Administration of immunomodulator within eight weeks of providing informed consent 10) A history of any biological agent administration 11) Miner who do not have guardian for appropriate administration of investigational agent 12) In certain circumstances that the researchers determined it was not suitable for the research
Age minimum:
1years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Chronic granulomatous disease associated colitis
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Intervention(s)
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Oral administration of thalidomide (1.5-3mg/kg), once a day
Oral administration of placebo (1.5-3mg/kg), once a day
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Primary Outcome(s)
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Ratio of subjects decreasing more than 20 points of Pediatric ulcerative colitis activity index (PUCAI) or being less than 10 of PUCAI score at the end of double-blind trial
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Secondary Outcome(s)
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1) Ratio of subjects being less than 10 of PUCAI score at the end of double-blind trial 2) Ratio of subjects decreasing more than one point of physician's global assessment (PGA) at the end of double-blind trial
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Source(s) of Monetary Support
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Japan Agency for Medical Research and Development
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Ethics review
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Status: YES
Approval date: 15/06/2017
Contact:
seiiku-chiken@ncchd.go.jp
National Center for Child Heath and Development
03-3416-0181
seiiku-chiken@ncchd.go.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2022 |
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URL:
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