UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Complete healing of small bowel ulcers (scores 3 or 4) in 8 weeks.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

ttanigawa@med.osaka-cu.ac.jp

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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