UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018885 |
|---|---|
| Receipt number | 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 | 2020/11/12 08:33:20 |
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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
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
hxnwq178@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 09 | 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
| 2015 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021847
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