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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009811
Receipt No. 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

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

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
URL(English) https://upload.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


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