UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009811
Receipt number R000011096
Scientific Title Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis
Date of disclosure of the study information 2013/01/21
Last modified on 2018/11/13 09:46:59

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Basic information

Public title

Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis

Acronym

Antibiotics trials for ulcerative colitis

Scientific Title

Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis

Scientific Title:Acronym

Antibiotics trials for ulcerative colitis

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A randomized controlled trial comparing two antibiotic regimens for ulcerative colitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Clinical remission and clinical response

Key secondary outcomes

Treatment failure rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint).

Interventions/Control_2

Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Eligibility criteria for study entry are mild-to-severe, chronically relapsing UC and a Lichtiger Clinical Activity Index of at least 6 or a Mayo score of more than 5.
2) Patients able to visit the hospital during follow up
3) Cases whose doctors decided that they would be able to provide adequate answers during an interview
4) Patients providing informed consent.

Key exclusion criteria

1) Patients with diarrhea and fever, unable take the medications and those with toxic megacolon
2) Patients allergic to penicillin
3) Patients allergic to SASP and 5-ASA
4) Pregnant patients. Cases with complications of other severe diseases, such as renal and hepatic disorders.
5) Patients with mental disorders, and so on, considered by their doctors to be unsuitable candidates for clinical trials

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimitoshi Kato

Organization

Nihon University School of Medicine, Itabshi Hospital

Division name

Division of Research Planning and Development

Zip code


Address

30-1 Oyaguchi-Kami machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

katou.kimitoshi@nihon-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kimitoshi Kato

Organization

Nihon University School of Medicine, Itabshi Hospital

Division name

Division of General Medicine, Dept. of Internal Medicine

Zip code


Address

30-1 Oyaguchi-Kami machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

katou.kimitoshi@nihon-u.ac.jp


Sponsor or person

Institute

Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine

Organization

Division

Category of Funding Organization

Other

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

日本大学医学部附属板橋病院


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 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

2012 Year 12 Month 17 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 23 Day

Last follow-up date

2018 Year 08 Month 30 Day

Date of closure to data entry

2018 Year 12 Month 30 Day

Date trial data considered complete

2018 Year 12 Month 30 Day

Date analysis concluded

2019 Year 03 Month 20 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 19 Day

Last modified on

2018 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name