UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024520 |
|---|---|
| Receipt number | R000028221 |
| Scientific Title | Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis |
| Date of disclosure of the study information | 2016/10/22 |
| Last modified on | 2018/10/01 15:36:47 |
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Basic information
Public title
Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis
Acronym
Antibiotic combination therapy(amoxicillin,tetracycline,metronidazole) for refractory UC
Scientific Title
Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis
Scientific Title:Acronym
Antibiotic combination therapy(amoxicillin,tetracycline,metronidazole) for refractory UC
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of safety and efficacy of antibiotics combination therapy for patients with ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate after 12 weeks(Mayo score) .
When it is these condition.
(1)The Mayo score decreases more than 30 % and, more than 3 decreases.
(2)The bleeding sub-score from the rectum is more than 1 decrease or less than 1.
Key secondary outcomes
(1)Remission rate after 12 weeks(Mayo score)
(2)Response rate and remission rate after 12 weeks(Mayo score) with refractory/inrefractory
(3)Endoscopic remission rate after 12 weeks(mucosal healing)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
placebo
Interventions/Control_2
metronidazole
Interventions/Control_3
metronidazole,amoxicillin
Interventions/Control_4
metronidazole,amoxicillin,tetracycline
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
UC patients who fits these condition.
(1)Moderate to severe ulcerative colitis(Mayo score the bleeding sub-score from more than 6 and the rectum 1 more than)
(2)In the screening endoscopy check day,patients fit at least 1 condition(1~4).
1 Patient who use 5-ASA(included SASP)more than 14 days.
2 Patient who use prednisolone below the 30mg/day for more than 14 days.
3 Patient who use AZA or 6-MP for more than 56 days.
4 Patient who use IFX or ADA for more than 56 days.
(3)In the agreement day,the patient who has passed for more than 84 days after who diagnosed as UC.
(4)In the agreement day,the patient who is more than 16 years old and less than 80 years old.
Key exclusion criteria
The patients who fit under one of them conditions is excluded.
(1)Patient who has allergy in metronidazole,amoxicillin,tetracycline.
(2)Patient who is infectious mononucleosis.(3)Patient who has a qualitative disease in a brain and a spinal cord.(4)Severe stricture colon.(5)Patient who has operation of large intestines.(Except for appendicitis.)(6)Patient who is a right or segmental colitis and/or acute fluminant colitis.
(7)Patient who is a infection colitis.
(8)The general cultivation check positive and/or a CD toxin positive and/or a parasite eggs in feces is a positive.
(9)Patient with a heart disease(over NYHA3),liver disease,kidney disease.
(10)Pregnant woman, lactating woman and the person who becomes pregnant.
(11)Patient with perforation of large intestines.
(12)The patients who fit under one of them conditions is excluded.
1.Prohibited combination use.
1)56 days before at the time of a screening endoscopy check day to 12 weeks later or cessation of all test. (cyclosporine, tacrolimus, methotrexate,Cytapheresis(Leukocyte Apheresis) 2)From 12 weeks before to cessation of all test. (Operation of large intestines) 3)From 14 days before at the time of prescription start date to the prescription end date. (antibacterial drug, antiviral drug,antifungal drug) 4)2.Restricted combination use.
(13)Patient who can't collect information including steroid treatment in medical record.(14)In the agreement day,patient who participates in other clinical trials.(15)In the screening endoscopy check day,patient who was taking other clinical trial medicine within 84 days.(16)Patient who can't stop drinking an alcohol during taking clinical trial medicine.
(17)Histoey of tic combination therapy(ATM/AFM treatment therapy)
(18)Patient who has the medical history of the malignant tumor in the past for 5 years.(Except for basal-cell carcinoma of skin and uterine cervical carcinoma in situ.)(19)Patient that physician determined inappropriate.
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Katsurada |
Organization
Hokkaido University Hospital
Division name
Endoscopy
Zip code
Address
N14,W5,Kita-Ku,Sapporo,Hokkaido,Japan
TEL
011-706-7715
tkatsu@amber.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nao Horie |
Organization
Hokkaido University Hospital
Division name
Clinical research and Medical innovation Center
Zip code
Address
N14,W5,Kita-Ku,Sapporo,Hokkaido,Japan
TEL
011-706-7735
Homepage URL
nhorie@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
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
2016年10月20日
Institutions
Institutions
医療法人徳洲会 札幌東徳洲会病院（北海道）
独立行政法人国立病院機構 函館病院（北海道）
東京慈恵会医科大学附属柏病院（千葉県）
東京慈恵会医科大学附属病院（東京都）
東京慈恵会医科大学葛飾医療センター（東京都）
国立研究開発法人 国立国際医療研究センター病院（東京都）
日本大学医学部附属板橋病院（東京都）
国立大学法人 富山大学附属病院（富山県）
国立大学法人 大分大学医学部附属病院（大分県）
公立大学法人 横浜市立大学附属病院（神奈川県）
国立大学法人 筑波大学附属病院（茨城県）
東京医科大学茨城医療センター（茨城県）
東海大学医学部附属八王子病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
北海道公立大学法人 札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 22 | 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
| 2016 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 10 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028221
