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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018885
Receipt No. R000021847
Scientific Title Effiacy of L-carnitine for NSAID-induced small-intestinal injuries in healthy volunteer subjects: a prospective, randomised, cross-over study
Date of disclosure of the study information 2015/09/03
Last modified on 2015/09/06

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Basic information
Public title Effiacy of L-carnitine for NSAID-induced small-intestinal injuries in healthy volunteer subjects: a prospective, randomised, cross-over study
Acronym Efficacy of L-carnitine for NSAID-induced small-intestinal injuries: intervention study
Scientific Title Effiacy of L-carnitine for NSAID-induced small-intestinal injuries in healthy volunteer subjects: a prospective, randomised, cross-over study
Scientific Title:Acronym Efficacy of L-carnitine for NSAID-induced small-intestinal injuries: intervention study
Region
Japan

Condition
Condition NSAIDs-induced small-intestinal mucosal injuries
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of L-carnitine for preventing NSAIDs-induced small-intestinal mucosal injuries
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparing the severity of small-intestinal mucosal injuries in video-capsule endoscopy immediately after intervention between users of L-carnitine and non-users
Key secondary outcomes Comparing the levels of oxidative-stress marker and cytokines in the serum, and the composition of intestinal bacterial flora immediately after intervention between users of L-carnitine and non-users

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Regimens are as follows;
Intervention A: indomethacin 25mg three times a day plus omeplazole 20mg once a day for seven days
Intervention B:indomethacin 25mg three times a day plus omeplazole 20mg once a dayplus L-carnitine 1000mg three times a day for seven days

Intervention 1 is as follows:
Intervention A, wash out for 4 weeks, Intervention B, and watching for 4 weeks
Interventions/Control_2 Intervention 2 is as follows:
Intervention B, wash out for 4 weeks, Intervention A, and watching for 4 weeks
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. healthy volunteers who have no comorbidities
2. all subjects are written informed consent
Key exclusion criteria 1. subjects who are taking gastric acid-inhibitory drugs (H2-blocker or PPI)
2. subjects who have been already takeing NSAID
3. subjects who have contraindications for using NSAID (gastroduodenal ulcer, bronchial asthma including aspirin asthma, severe blood diseases/hapatic injuries/renal injuries/heart failure/hypertention/pancreatitis, pregnancy and lactation, triamterene users
4. past history of abdominal surgery or ileus
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Okada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Email hiro@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyasu Kono
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Homepage URL
Email hxnwq178@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
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
2015 Year 09 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
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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 03 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
2015 Year 09 Month 02 Day
Last modified on
2015 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021847

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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