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UMIN-CTR Clinical Trial |
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Recruitment status | |
Unique ID issued by UMIN | C000000061 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Chronic obstructive pulmonary disease | |
Classification by specialty |
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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 |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
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 |
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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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
nnagaya@ri.ncvc.go.jp |
Sponsor | |
Institute | National Cardiovascular Center Research Institute |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000103 |