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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001598
Receipt No. R000001920
Scientific Title Effect of ghrelin on airway inflammation in patients with chronic lower respiratory infection
Date of disclosure of the study information 2009/01/05
Last modified on 2012/05/02

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Basic information
Public title Effect of ghrelin on airway inflammation in patients with chronic lower respiratory infection
Acronym Effect of ghrelin on airway inflammation
Scientific Title Effect of ghrelin on airway inflammation in patients with chronic lower respiratory infection
Scientific Title:Acronym Effect of ghrelin on airway inflammation
Region
Japan

Condition
Condition chronic lower respiratory infection
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether ghrelin suppresses airway inflammation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes volume of sputum
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
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 (2microgram/kg, 20 mL solution) was intravenously administered to the patients for 30 min at a constant rate before breakfast and dinner for 2 weeks continuously. After one week interval, the same volume of salin was intravenously administered to the patients for 30 min at a constant rate before breakfast and dinner for 2 weeks continuously.
Interventions/Control_2 Twenty ml of salin was intravenously administered to the patients for 30 min at a constant rate before breakfast and dinner for 2 weeks continuously. After one week interval, human ghrelin (2microgram/kg, 20 mL solution) was intravenously administered to the patients for 30 min at a constant rate before breakfast and dinner for 2 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) persistent productive cough with purulent sputum for >6 months
2) isolation of multidrug-resistant pathogens from sputum
3) BMI<21kg/m2
Key exclusion criteria 1) patients with diabetes mellitus, severe cardiac disease, hepatic disease, renal insufficiency
2) pregnant women
3) patients with infections in other organs than the lungs
Target sample size 40

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
Email

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
TEL
Homepage URL
Email

Sponsor
Institute Miyazaki University School of Medicine
Institute
Department

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
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
2009 Year 01 Month 05 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
2008 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 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 12 Month 25 Day
Last modified on
2012 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001920

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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