UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011076 |
|---|---|
| Receipt number | R000012961 |
| Scientific Title | A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2014/04/15 11:27:12 |
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Basic information
Public title
A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding
Acronym
A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding
Scientific Title
A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding
Scientific Title:Acronym
A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding
Region
| Japan | Asia(except Japan) |
Condition
Condition
small bowel ulcers in aspirin users with small bowel bleeding
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate a new treatment (misoprostol) for the healing of small bowel ulcers in users of low-dose aspirin (ASA) complicated by small bowel bleeding.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete healing of small bowel ulcers (scores 3 or 4) in 8 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
misoprostol 800 micro g/day
Interventions/Control_2
placebo
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. suspected small bowel overt bleeding – melena or hematochezia with normal upper endoscopy and colonoscopy,
2. suspected small bowel occult blood loss – defined as a significant decrease in hemoglobin (> 2g/dL), with normal upper endoscopy and colonoscopy, confirmed iron deficiency anemia, and absence of other identifiable causes for hemoglobin decrease (e.g. fluid overload, progressive renal failure, malnutrition, or other hematological disorders such as hemolysis or malignancies)
3. continuous use of ASA for the duration of the trial
4. age ≥ 20
5. written informed consent obtained
Key exclusion criteria
1. increased risk of capsule retention (e.g. gastric outlet obstruction, bypass surgery, Crohn's disease or suspected small bowel stricture)
2. abnormal findings on upper endoscopy (e.g. esophageal varices, grade C or D erosive esophagitis, vascular malformations, ulcer more than five erosions, neoplasms) or colonoscopy (e.g. cancer, polyps >1 cm, inflammatory bowel disease, vascular malformations, bleeding hemorrhoids or diverticular disease)
3. unable to swallow the video capsule
4. terminal illness
5. concomitant use of NSAIDs, sucralfate, rebamepide, anticoagulants, corticosteroids (prednisolone >7.5 mg daily or equivalent), and iron supplement
6. pregnancy or women of child-bearing age without regular use of contraception
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Arakawa |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku Osaka City, Osaka 545-8585, Japan
TEL
0666453811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Tanigawa |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
ttanigawa@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
大阪市立大学 消化器内科（大阪府）
香港中文大学 消化器内科（香港）
佐賀大学 内科学（佐賀県）
大阪医科大学 第二内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 29 | Day |
Last modified on
| 2014 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012961
