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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012216
Receipt No. 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

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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
Email 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
Email asagiri@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014259

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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