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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002498
Receipt No. R000003062
Scientific Title Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Date of disclosure of the study information 2009/09/15
Last modified on 2010/05/25

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Basic information
Public title Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Acronym Investigation of mucosal protective agents for small intestinal mucosal injury.
Scientific Title Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Scientific Title:Acronym Investigation of mucosal protective agents for small intestinal mucosal injury.
Region
Japan

Condition
Condition NSAID-induced small-intestinal mucosal injury
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the rate of the incidence of small intestinal mucosal injury induced by loxoprofen and to investigate the inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of the incidence of small intestinal mucosal injury evaluated with capsule endoscopy.
Key secondary outcomes 1. Anemia (Evaluated by blood test results before and after the administration of the medicines)
2. Small bowel transit time of capsule endoscopy.
3. Subjective symptoms
4. Confirmation of adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.Loxoprofen, Omeprazole and irsogladine maleate
2.washout period
3.Loxoprofen, Omeprazole and placebo
Interventions/Control_2 1.Loxoprofen, Omeprazole and placebo
2.washout period
3.Loxoprofen, Omeprazole and irsogladine maleate
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 H. Pylori negative volunteers aged 20 years or older, who understand the meaning and purpose of this clinical study and have consented to participate in it. They need to have a history of pain-causing conditions such as lumbago, frozen shoulder, Cervico-omo-brachial syndrome, arthalgia, myalgia, toothache, trauma, acute upper respiratory tract infection, headache and neuralgia and are considering NSAIDs use in future
Key exclusion criteria 1) People with dysphagia.
2) People with organ dysfunction such as kidney disease, liver disease and heart disease.
3) Pregnant or possibility of pregnancy.
4) People with a history of allergic reactions to NSAIDs(nonsteroidal antiinflammatory drug) or other drugs. People with allergies.
5) People with history of asthma.
6) People with history of gastrointestinal surgeries, or who are suspicious of having a stenosis of the gastrointestinal tract.
7) People with a history of gastrointestinal hemorrhage or ulcer diseases.
8) People who are diagnosed with ulcers, apparent hemorrhagic lesions or tumors in the lower gastrointestinal tract by capsule endoscopy.
9) People with positive results of H. Pylori test.
10) People with a history of H.pylori eradication therapy.
11) People who are taking any kinds of medicines or took them within one month. Use of NSAIDs and mucosal protectant should be carefully excluded in particular.
12) People who are judged not suitable for the study by the investigator in charge or other investigators.
Target sample size 19

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Yamamoto
Organization Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University
Division name Department of Endoscopic Research and International Education (Funded by Fujifilm)
Zip code
Address 3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
TEL 0285-58-7539
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Nishimura
Organization Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University
Division name Department of Medicine, Division of Gastroenterology
Zip code
Address 3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
TEL 0285-58-7539
Homepage URL
Email naoyukin@jichi.ac.jp

Sponsor
Institute Department of Endoscopic Research and International Education (Funded by Fujifilm)
in Jichi Medical University
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
2009 Year 09 Month 15 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 Completed
Date of protocol fixation
2009 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 15 Day
Last modified on
2010 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003062

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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