UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029324 |
|---|---|
| Receipt number | R000033119 |
| Scientific Title | Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/09/30 10:13:05 |
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Basic information
Public title
Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis
Acronym
Clinical trial of thalidomide for CGD colitis
Scientific Title
Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis
Scientific Title:Acronym
Clinical trial of thalidomide for CGD colitis
Region
| Japan |
Condition
Condition
Chronic granulomatous disease associated colitis
Classification by specialty
| Medicine in general | Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess a safety and efficacy of thalidomide for chronic granulomatous disease-associated colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of thalidomide (1.5-3mg/kg), once a day
Interventions/Control_2
Oral administration of placebo (1.5-3mg/kg), once a day
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of CGD colitis, ages over one year
2) Moderate CGD colitis (35 /<= PUCAI < 65), or Mild CGD colitis (10 /<= PUCAI <35) carrying bloody stool or over six times of defecation at the onset or relapse
3) Signed informed consent form agreeing to the clinical trial participation
4) Informed consent to compliance rules including administration of investigational agent and contraception
Key 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
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Toshinao |
| Middle name | |
| Last name | Kawai |
Organization
National Center for Child Heath and Development
Division name
Division of Immunology
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
kawai-t@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Sako |
Organization
National Center for Child Heath and Development
Division name
Division of Child Health and Development
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
sako-m@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Heath and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Heath and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
seiiku-chiken@ncchd.go.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
国立研究開発法人国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033119
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| Registered date | File name |
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