UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000029912