UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026828 |
|---|---|
| Receipt number | R000029912 |
| Scientific Title | A pilot study to evaluate the effect of colchicine treatment on NSAID-induced small intestinal damage |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2019/04/10 18:08:37 |
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Basic information
Public title
A pilot study to evaluate the effect of colchicine treatment on NSAID-induced small intestinal damage
Acronym
Effect of colchicine on NSAID-induced small intestinal damage (a pilot study)
Scientific Title
A pilot study to evaluate the effect of colchicine treatment on NSAID-induced small intestinal damage
Scientific Title:Acronym
Effect of colchicine on NSAID-induced small intestinal damage (a pilot study)
Region
| Japan |
Condition
Condition
NSAID-induced small intestinal damage
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of colchicine treatment on NSAID-induced small intestinal damage and establish the new therapeutics for gastrointestinal complications by NSAIDs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete healing rate of small intestinal erosions and ulcers in 8 weeks of colchicine administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prescribe one tablet of colchicine (0.5 mg) twice a day for 8 weeks.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) More than 20 years old
2) Possible oral administration
3) Written informed consent obtained
4) Patients with category 3 (more than 5 erosions) or 4 (large erosion or ulcer) defined by Graham DY (Graham DY et al. Clin Gastroenterol Hepatol, 2005)
Key exclusion criteria
1) Malignant tumor or severe systemic disease (CNS disase or psychiatric disease)
2) Crohns disease, intestinal tuberculosis, or known gastrointestinal stricture
3) Unable to swallow the video capsule
4) Pacemaker
5) Concomitant use of antibiotics
6) Severe liver disease
7) Severe renal disease
8) Hypersensitivity for colchicine
9) Pregnant or lactating women
10) Active small bowel bleeding (Patients with endoscopic hemostasis or intravascular embolization can be enrolled.)
11) Inadequate judged by PI
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Otani |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585
TEL
06-6645-3811
kojiotani@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Otani |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585
TEL
06-6645-3811
Homepage URL
kojiotani@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 03 | 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
8
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029912
