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
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
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
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
