UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012216 |
|---|---|
| Receipt number | R000014259 |
| Scientific Title | Treatment with supplementary L-ornithine in patients with pressure ulcers. |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2013/11/05 15:18:16 |
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Basic information
Public title
Treatment with supplementary L-ornithine in patients with pressure ulcers.
Acronym
L-ornithine ingestion for pressure ulcers
Scientific Title
Treatment with supplementary L-ornithine in patients with pressure ulcers.
Scientific Title:Acronym
L-ornithine ingestion for pressure ulcers
Region
| Japan |
Condition
Condition
Pressure ulcer
Classification by specialty
| Surgery in general | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of L-ornithine supplementation on the healing of pressure ulcers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DESIGN-R score, blood prealbumin, blood retinol-binding protein, blood transferrin, urinary 3-methyl-histidine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing 2.5 g of L-ornithine per day (ORNUTE; KYOWA HAKKO BIO CO., LTD., Tokyo, Japan) was administered for 8 weeks by orally or enterally, twice daily (morning and evening).
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*The Omuta Memorial Hospital (Fukuoka, Japan) inpatients with Shea's Pressure Sores Classification grade 2 and more
*Patients from whom or whose legal representative written informed consent is obtained
Key exclusion criteria
*Patients with history of high hypersensitivity
*Patients with renal disease who is inadequate for the study
*Patients with following conditions which may affect the blood albumin level irrelevantly to nutritional status
-Malignancy
-Acute inflammatory diseases such as infectious disease
-Serious hepatic disorders such as cirrhosis
-Severe burn or injury
-History of metabolic disorders of amino acid
*Patients at risk of acquiring allergy related the study
*Patients with remarkable higher or lower laboratory values or physiological measurement than reference value
*Patients included in other clinical studies within 3 months or in process
*Patients with other conditions which principal investigator consider inadequate such as routine users of similar food (e.g. amino acid supplement)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimio Asagiri |
Organization
Kurume University School of Medicine
Division name
Department of Pediatric Surgery, Kurume University School of Medicine
Zip code
Address
67, Asahimachi, Kurume-Shi, Fukuoka, 830-0011, Japan
TEL
+81-942-31-7631
asagiri@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimio Asagiri |
Organization
Kurume University School of Medicine
Division name
Department of Pediatric Surgery, Kurume University School of Medicine
Zip code
Address
67, Asahimachi, Kurume-Shi, Fukuoka, 830-0011, Japan
TEL
+81-942-31-7631
Homepage URL
asagiri@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KYOWA HAKKO BIO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
大牟田記念病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 18 | 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
| 2013 | Year | 11 | Month | 05 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014259
