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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029324
Receipt No. 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 2019/04/17

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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
Email 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
Email sako-m@ncchd.go.jp

Sponsor
Institute National Center for Child Heath and Development
Institute
Department

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
Email 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
2021 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
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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