UMIN-CTR Clinical Trial

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

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

Email

tkatsu@amber.plala.or.jp

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

Email

nhorie@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2016

Year

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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