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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008114
Receipt No. R000009552
Scientific Title Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Esophagitis, Peptic Ulcers, Small Intestinal Lesions in Volunteers
Date of disclosure of the study information 2012/06/06
Last modified on 2012/06/06

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Basic information
Public title Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Esophagitis, Peptic Ulcers, Small Intestinal Lesions in Volunteers
Acronym Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Alimentary Tract Lesions
Scientific Title Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Esophagitis, Peptic Ulcers, Small Intestinal Lesions in Volunteers
Scientific Title:Acronym Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Alimentary Tract Lesions
Region
Japan

Condition
Condition NSAID induced Alimentary Tract Lesions
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the efficacy of irsogladine and omeprazole on esophagitis, peptic ulcers, small bowel intestinal lesions induced by short-term NSAID administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of small intestinal mucosal breaks evaluated in the capsule endoscope.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 irsogladine 4mg/day and dicrofenacNa 75mg/day for 2 weeks in oral administration
Interventions/Control_2 omeprazole 10mg/day and dicrofenacNa75mg/day for 2 weeks in oral administration
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining
consent
2) Subjects from whom fully informed written consent based on their full understanding and their
own voluntary will was obtained when participating this study
3)Subjects who had taken no medication during the 1-month period before the start of this study
Key exclusion criteria 1) Subjects with a history of peptic ulcer or gastrointestinal bleeding
2) Subjects with significant hepatic disease, renal disease, heart disease, or respiratory disease
3) Subjects with a history of gastrointestinal surgery other than appendectomy
4) Subjects orally taking or planning to orally take drug other than antiulcer drug or NSAIDs
5) Subjects with alcohol or chemical dependencies
6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal
obstruction on other tests
7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body
8) Subjects whom otherwise the investigator determined ineligible as the subject
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 Daigakumachi Takatsuki Osaka 569-8686 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Second Department of Internal Medicine, Osaka Medical College
Institute
Department

Funding Source
Organization None
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
2012 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 10 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
2012 Year 06 Month 06 Day
Last modified on
2012 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009552

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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