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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019249
Receipt No. R000022250
Scientific Title Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents
Date of disclosure of the study information 2015/10/06
Last modified on 2018/04/07

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Basic information
Public title Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents
Acronym clinical efficacy of Qing-Dai for patients with crohn's disease
Scientific Title Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents
Scientific Title:Acronym clinical efficacy of Qing-Dai for patients with crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the clinical efficacy and safety of Qing-Dai in patients with Crohn's disease who have the loss of responsiveness for anti-TNF agents
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of clinical remission (CDAI is less than 150 at 8 weeks after the entry)
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
Medicine
Interventions/Control_1 Eight weeks treatment of Qing-Dai (2g daily)
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Japanese patient who is aged more than15 years
2 Patients were diagnosed according to the diagnostic criteria defined by the research group of inflammatory bowel disease in the Ministry of Health, Labor and Welfare in Japan.
3 Patients induced clinical remission by infliximab or adalimumab once, and then infliximab or adalimumab was used at least for 16 weeks after starting ofinfliximab or adalimumab.
4 Patients' CDAI was more than 175 at the entry and at last administration of infliximab or adalimumab
Key exclusion criteria 1 Patients' CDAI was more than 450 or less than 150 at the entry
2 The patients were not treated with infliximab within 7 weeks. The patients were not treated with adalimumab within 10 days.
3 The presence of abdominal abscess
4 Patients had colitis-associated dysplasia.
5 Patients had symptomatic intestinal stenosis
6 Patients had pouch or stoma.
7 Patients have the history of side effect or allergy of Chinese herbal medicine.
8 Patients have serious infections.
9 Patients have serious heart disease
10 Serum creatinine is more than 2.0mg/dL
11 Total bilirubin is more than 2.0mg/dL or AST/ALT is more than 50IU/L
12 Patients have history of malignant diseases
13 Patients have obvious psychological disorders
14 Patients are pregnant or patients wish to conceive.
15 Changing the dose/addition/reduction of medication for CD within 12 weeks before the commencement of the study was not allowed.
16 Investigators regard the patients as the inappropriate person to enroll this clinical trial.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Naganuma
Organization School of Medicine, Keio University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email maknaganuma@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Naganuma
Organization School of Medicine, Keio University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email maknaganuma@gmail.com

Sponsor
Institute Division of Gastroenterology and Hepatology, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Keio University Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 06 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 Terminated
Date of protocol fixation
2015 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 06 Day
Last modified on
2018 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022250

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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