UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009789 |
|---|---|
| Receipt number | R000011467 |
| Scientific Title | Efficacy of elemental diet, Elental on maintenance therapy of Crohn's disease after remission with anti-TNFa antibody.(non-randomized control study) |
| Date of disclosure of the study information | 2013/01/16 |
| Last modified on | 2016/07/25 18:10:51 |
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Basic information
Public title
Efficacy of elemental diet, Elental on maintenance therapy of Crohn's disease after remission with anti-TNFa antibody.(non-randomized control study)
Acronym
Additional Power of Elemental Diet (Elental)on Maintenance Biologics therapy in Crohn's Disease. (ADORE Study)
Scientific Title
Efficacy of elemental diet, Elental on maintenance therapy of Crohn's disease after remission with anti-TNFa antibody.(non-randomized control study)
Scientific Title:Acronym
Additional Power of Elemental Diet (Elental)on Maintenance Biologics therapy in Crohn's Disease. (ADORE Study)
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the usefulness of elemental diet combination with biologics treatment for maintenance remission of Crohn's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The occurrence of relapse (Relapse was defined by: (1) increase in CDAI of at least 70 points from the baseline score with a total score of at least 220, (2) shortening of biologics dosing interval (3) introduction of a new treatment for active Crohn's disease)
Key secondary outcomes
Response rate, safety assesment
Others
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients take >=900 kcal/day elemental diet, combination with scheduled biologics treatment.
Interventions/Control_2
Patients dose not use any enteral diet therapy, combination with scheduled biologics treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Moderate to severe (CDAI 220-400) patients.
Patients who are introduced anti-TNFa antibody as induction therapy.
Patients approving the study consent.
Key exclusion criteria
Patients in 16 weeks after last biologics dosing or after bowel resection.
Patients with stoma.
Parenteral nutrition dependent patients with short bowel syndrome or others.
Biologics intolerance.
Patients judged as inadequate at the discretion of physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Matsui |
Organization
Fukuoka University Chikushi Hospital
Division name
Depertment of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikushino, Fukuoka, JAPAN
TEL
092-921-1011
syokaki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihito Hirai |
Organization
Fukuoka University Chikushi Hospital
Division name
Depertment of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikushino, Fukuoka, JAPAN
TEL
092-921-1011
Homepage URL
syokaki@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福岡大学筑紫病院（福岡県）、九州大学（福岡県）、福岡大学（福岡県）、福岡山王病院（福岡県）、九州中央病院（福岡県）、福岡赤十字病院（福岡県）、浜の町病院（福岡県）、千鳥橋病院（福岡県）、久留米大学（福岡県）、くるめ病院（福岡県）、戸畑共立病院（福岡県）、産業医科大学（福岡県）、佐賀大学（佐賀県）、大分赤十字病院（大分県）、長崎大学（長崎県）、井上病院（長崎県）、聖フランシスコ病院（長崎県）、長崎市民病院（長崎県）、長崎原爆病院（長崎県）、光晴会病院（長崎県）、高野病院（熊本県）、済生会熊本病院（熊本県）、今村病院（鹿児島県）、宮崎大学（宮崎県）、古賀総合病院（宮崎県）、琉球大学（沖縄県）、浦添総合病院（沖縄県）、中頭病院（沖縄県）、那覇市立病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 16 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2013 | Year | 01 | Month | 16 | Day |
Last modified on
| 2016 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011467
