UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000078 |
|---|---|
| Receipt number | R000000114 |
| Scientific Title | Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study |
| Date of disclosure of the study information | 2005/08/26 |
| Last modified on | 2012/11/30 00:32:07 |
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Basic information
Public title
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Acronym
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis
Scientific Title
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Scientific Title:Acronym
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether an antibiotic combination therapy against Fusobacterium varium is effective and safe for relapsing and refractory ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
symptom assessment, endoscopic and histological evaluations, laboratory findings
Key secondary outcomes
the titers of antibody to F. varium and the F. varium density in the mucosa
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in the treatment group receive an antibiotic combination consisting of amoxicillin 500mg tid, tetracycline 500mg tid, and metronidazole 250mg tid for two weeks.
Interventions/Control_2
patients in the control group recieve three kinds of placebo contained sugar.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic relapsing and refractory ulcerative colitis patients who have inflammatory colonic mucosa and who attend regular outpatient or inpatient clinics at the Department of Gastroenterology
Key exclusion criteria
Patients are excluded if they have toxic megacolon, if they have allergy to penicillin, if they are pregnant, if they have serious liver or renal disease or if they have psychological disease. In addition, patients who have taken antibiotics within four weeks of study entry and have Clostridium difficle or other stool pathogens at entry are excluded.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Sato |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Ohkusa |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ohkusa@med.juntendo.ac.jp
Sponsor or person
Institute
Japan UC Antibiotics-therapy Study Group(JUCASG)
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon University,Iwate Medical University, Kyoto Central Hospital
Yamagata Central Hospital
Oita University, Tokyo Medical University
Toyama Medical & Pharmaceutical University, Showa University
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
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 2-week triple antibiotic therapy produced improvement, remission, and steroid withdrawal in
active UC more effectively than a placebo.
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
| 2003 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 12 | Month | 01 | Day |
Other
Other related information
Ohkusa T, Kato K, Terao S, Chiba T, Mabe K, Murakami K, Mizokami Y, Sugiyama T, Yanaka A, Takeuchi Y, Yamato S, Yokoyama T, Okayasu I, Watanabe S, Tajiri H, Sato N. Newly Developed Antibiotic Combination Therapy for Ulcerative Colitis: A Double-Blind Placebo-Controlled Multicenter Trial. Am J Gastroenterol. 2010 Aug;105(8):1820-9.
Management information
Registered date
| 2005 | Year | 08 | Month | 25 | Day |
Last modified on
| 2012 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000114
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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