UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001512 |
|---|---|
| Receipt number | R000001822 |
| Scientific Title | Clinical trial with ghrelin for patients with chronic respiratory failure |
| Date of disclosure of the study information | 2008/12/01 |
| Last modified on | 2012/05/02 16:04:20 |
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Basic information
Public title
Clinical trial with ghrelin for patients with chronic respiratory failure
Acronym
Ghrelin treatment for chronic respiratory failure
Scientific Title
Clinical trial with ghrelin for patients with chronic respiratory failure
Scientific Title:Acronym
Ghrelin treatment for chronic respiratory failure
Region
| Japan |
Condition
Condition
chronic respiratory failure
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of ghrelin on exercise tolerance in patients with chronic respiratory failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-min walking distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Human ghrelin (1 microgram/kg, 10 mL solution) was intravenously administered to the patients for 30 min at a constant rate before breakfast and dinner for 3 weeks continuously.
Interventions/Control_2
Human ghrelin (2 microgram/kg, 10 mL solution) was intravenously administered to the patients for 30 min at a constant rate before breakfast and dinner for 3 weeks continuously.
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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)cachectic patient with chronic respiratory failure (BMI<21kg/m2)
2)the underlying disease, which is chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, and/or old tuberculosis, is stable within 2 months prior to the study
Key exclusion criteria
1)patient with cancer (and/or post-operative state), lymphangiomyomatosis, lymphoproliferative disease, collagen lung, neuromuscular disease, primary hypoventilation syndrome, pneumoconiosis, eosinophilic granulomatosis, and/or diffuse panbronchiolitis
2)patient with diabetes mellitus (HbA1c>8.0)
3)patient with severe heart disease
4)patient with liver dysfunction
5)patient with renal dysfunction
6)pregnant woman
7)patient with dementia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakazato Masamitsu |
Organization
Miyazaki University school of Medicine
Division name
Third Department of Internal Medicine
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Miyazaki University school of Medicine
Division name
Third Department of Internal Medicine
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
Homepage URL
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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
| 2008 | Year | 11 | Month | 18 | Day |
Last modified on
| 2012 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001822
