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Recruitment status Terminated
Unique ID issued by UMIN UMIN000010233
Receipt No. R000011981
Scientific Title Palliative effect of interaperitoneal administration of triamcinolone acetonide in patients with malignant peritonitis
Date of disclosure of the study information 2013/03/13
Last modified on 2017/03/20

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Basic information
Public title Palliative effect of interaperitoneal administration of triamcinolone acetonide in patients with malignant peritonitis
Acronym Intraperotoneal administration of Kenacolt
Scientific Title Palliative effect of interaperitoneal administration of triamcinolone acetonide in patients with malignant peritonitis
Scientific Title:Acronym Intraperotoneal administration of Kenacolt
Region
Japan

Condition
Condition refractory patients with malignant peritonitis
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intraperitoneal administration of triamcinolone acetonide
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to the next abdominal puncture
Key secondary outcomes

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 Triamcinolone acetonide
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
99 years-old >
Gender Male and Female
Key inclusion criteria 1. Refractory malignant peritonitis required the abdoninal puncture over twice per two weeks
2. not indicated patinets with chemotherapy
3. life ecpectancy less than 6 months
4. more than 20 years old
5. Written informed consent
Key exclusion criteria 1. bloody ascitis
2. infectious peritonitis
3. in controlled diabetes mellitus (HbA1c; more than 8.5%)
4. Pregnant or breast feeding woman
5. Not available for follow-up assesments or unable to comply with study
Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Takeda
Organization Osaka City General Hospital
Division name Dept. of Clinical Oncology
Zip code
Address 2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, Japan
TEL 06-6929-1221
Email ko-takeda@med.osakacity-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Katayama
Organization Osaka City General Hospital
Division name Dept. of palliative amedicine
Zip code
Address 2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, Japan
TEL 06-6929-1221
Homepage URL
Email ko-takeda@med.osakacity-hp.or.jp

Sponsor
Institute Koji Takeda
Institute
Department

Funding Source
Organization Dept.of Clincial Oncology, Osaka City General Hospital
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 03 Month 13 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 No patients was entered in this study.
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
2013 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 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
2013 Year 03 Month 13 Day
Last modified on
2017 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011981

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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