Unique ID issued by UMIN | C000000061 |
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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 |
Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease
Ghrelin therapy for chronic obstructive pulmonary disease
Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease
Ghrelin therapy for chronic obstructive pulmonary disease
Japan |
Chronic obstructive pulmonary disease
Pneumology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
QOL score (SGRQ)
Six-minute walk distance
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is considered as a block.
YES
No need to know
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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
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
60
1st name | |
Middle name | |
Last name | Kenji Kangawa |
National Cardiovascular Center Research Institute
Deputy Director of Research Institute
5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan
06-6833-5012
1st name | |
Middle name | |
Last name | Noritoshi Nagaya |
National Cardiovascular Center Research Institute
Department of Regenerative Medicine & Tissue Engineering
5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan
06-6833-5012
nnagaya@ri.ncvc.go.jp
National Cardiovascular Center Research Institute
Ministry of Health, Labour, and Welfare
Japan
Toneyama National Hospital
Nara Medical University
Faculty of Medicine, University of Miyazaki
Osaka City University Medical School
National Institute of Biomedical Innovation the Promotion of Fundamental Studies in Health Science
NO
2005 | Year | 08 | Month | 15 | Day |
Unpublished
2005 | Year | 07 | Month | 01 | Day |
2005 | Year | 09 | Month | 01 | Day |
2006 | Year | 09 | Month | 01 | Day |
2005 | Year | 08 | Month | 15 | Day |
2010 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000103
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