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

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 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


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

Value
https://center6.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