UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000061
Receipt number R000000103
Scientific Title Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2005/08/15
Last modified on 2010/08/03 16:11:19

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Basic information

Public title

Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease

Acronym

Ghrelin therapy for chronic obstructive pulmonary disease

Scientific Title

Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease

Scientific Title:Acronym

Ghrelin therapy for chronic obstructive pulmonary disease

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the present study is to investigate the effects of ghrelin administration in cachexic patients with chronic obstructive pulmonary disease in a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

QOL score (SGRQ)
Six-minute walk distance

Key secondary outcomes

QOL score (SF-36)
Medical Research Council (MRC) dyspnea scale
Food intake
Vital capacity (VC)
FEV1%
Maximal inspiratory pressure
Maximal expiratory pressure
Plasma norepinephrine level
Peak oxygen uptake


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Synthetic human ghrelin (2ug/kg, dissolved in 10 ml of sterile saline) is administered to cachexic patients with COPD participating in pulmonary rehabilitation (cycle ergometer training). Ghrelin is administered intravenously for 30 minutes. The infusion is repeated twice a day (before breakfast and before dinner) for three weeks.

Interventions/Control_2

Sterile saline (10mL) is administered to cachexic patients with COPD participating in pulmonary rehabilitation (cycle ergometer training). Saline is administered intravenously for 30 minutes. The infusion is repeated twice a day (before breakfast and before dinner) for three 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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with moderate to severe COPD (FEV1% < 70%, %FEV1 < 50%)
Patients with weight loss (BMI < 21kg/m^2)
Patients whose conditions are stable and who can participate in pulmonary rehabilitation
Patients who are between 20 and 85 in age
Patients who have signed the agreement for participation in this study

Key exclusion criteria

Patients with malignant tumors
Patients with active infection
Patients with severe heart disease
Patients with hepatic failure (serum levels of AST and ALT greater than twice the normal upper limit)
Patients with renal failure (serum creatinine concentration >= 2.0 mg/dL)
Patients with asthma
Patients who are or could be pregnant
Patients whose drug regimen was changed within one month before participation in this study
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Kangawa

Organization

National Cardiovascular Center Research Institute

Division name

Deputy Director of Research Institute

Zip code


Address

5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan

TEL

06-6833-5012

Email



Public contact

Name of contact person

1st name
Middle name
Last name Noritoshi Nagaya

Organization

National Cardiovascular Center Research Institute

Division name

Department of Regenerative Medicine & Tissue Engineering

Zip code


Address

5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan

TEL

06-6833-5012

Homepage URL


Email

nnagaya@ri.ncvc.go.jp


Sponsor or person

Institute

National Cardiovascular Center Research Institute

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Toneyama National Hospital
Nara Medical University
Faculty of Medicine, University of Miyazaki
Osaka City University Medical School

Name of secondary funder(s)

National Institute of Biomedical Innovation the Promotion of Fundamental Studies in Health Science


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

2005 Year 08 Month 15 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

Date of protocol fixation

2005 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 09 Month 01 Day

Last follow-up date

2006 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

2005 Year 08 Month 15 Day

Last modified on

2010 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000103


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name