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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014358
Receipt No. R000016641
Scientific Title Efficacy and Safety of pleurodesis with 50% glucose solution: an open-label, uncontrolled study
Date of disclosure of the study information 2014/06/23
Last modified on 2017/04/17

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Basic information
Public title Efficacy and Safety of pleurodesis with 50% glucose solution: an open-label, uncontrolled study
Acronym Efficacy and Safety of pleurodesis with 50% glucose solution: an open-label, uncontrolled study
Scientific Title Efficacy and Safety of pleurodesis with 50% glucose solution: an open-label, uncontrolled study
Scientific Title:Acronym Efficacy and Safety of pleurodesis with 50% glucose solution: an open-label, uncontrolled study
Region
Japan

Condition
Condition Refractory pneumothorax or malignant pleural effusion
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of pleurodesis with 50% glucose solution for patients with refractory pneumothorax or malignant pleural effusion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effectiveness of pleurodesis with 50% glucose solution
Key secondary outcomes 1.Dyspnea and chest pain
2.Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pleurodesis by intrapleural administration of 200ml of 50% glucose solution
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with pneumothorax or malignant pleural effusion
2.Written informed consent
Key exclusion criteria 1.uncontrollable diabetes
2.unstable angina or myocardial infarction within one month
3.pregnancy
4.inappropriate patients for this study judged by the physicians
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamitsu Nakazato
Organization University of Miyazaki
Division name Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine
Zip code
Address Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL 0985-85-2965
Email nakazato@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuji Arimura
Organization University of Miyazaki
Division name Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL 0985-85-2965
Homepage URL
Email yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
Organization
Division
Category of Funding Organization Other
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
2014 Year 06 Month 23 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 Terminated
Date of protocol fixation
2014 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 23 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016641

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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