UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014358 |
|---|---|
| Receipt number | 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 08:59:45 |
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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
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
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016641
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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