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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005762
Receipt No. R000006812
Scientific Title The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
Date of disclosure of the study information 2011/06/13
Last modified on 2018/12/19

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Basic information
Public title The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
Acronym The Efficacy of Adalimumab
Scientific Title The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
Scientific Title:Acronym The Efficacy of Adalimumab
Region
Japan

Condition
Condition Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy and safety of Adalimumab conbined elemental diet therapy for Crohn's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1)Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.

2)Elental(1 kcal/ml; 80g/300ml)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
Key exclusion criteria 1)The patient who has internal fistula
2)The patient who is planning to have an operation
3)The patient who is short bowel syndorome
4)The patient of contraindication for adalimumab or Elental
5)The case which is hard to get the patient's consent
6)The patient who was judged for unsuitable by responsibility doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Watanabe
Organization Osaka City University Gradatescool of Medicine
Division name Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University Gradatescool of Medicine
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email nkamata@med.osaka-cu.ac.jp

Sponsor
Institute Kenji Watanabe
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 27 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
2011 Year 06 Month 13 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006812

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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