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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026828
Receipt No. 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

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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
Email 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
Email kojiotani@med.osaka-cu.ac.jp

Sponsor
Institute Department of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029912

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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