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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027441
Receipt No. R000031431
Scientific Title The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Date of disclosure of the study information 2017/05/23
Last modified on 2017/05/22

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Basic information
Public title The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Acronym Hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Scientific Title The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Scientific Title:Acronym Hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Region
Japan

Condition
Condition Resectable pancreatic cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In pancreatic cancer, we examine the safety and anti-tumor effect of 3-oxygelmillpropionic acid polymer (a trade name: Seroshion) .
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes efficacy

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 The dose of Seroshion is 1 capsule (10mg) /time after each meal (3 times/day,30mg/day). The administration period is six months.
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) The case who was diagnosed histologically pancreatic cancer (2)The case who underwent R0 resection for pancreatic cancer.(3)The age is over 20 years old.(4)PS (ECOG) is 0 or 1. (5)Within 14 days before,major organ function is held by clinical examination.1)WBC is above 3,000 / mm3 and below 12,000/mm3. 2)Plt is above 100,000/mm3, 3)Hb is above 8.0g / dL, 4)AST (GOT) is below 100IU / L, and ALT (GPT)is below 100IU/L. 5)T-bil is below 2.0mg/dL. 6)Cr is below 1.2mg/dL 7)Ccr is above 50mL/min. (6)The patients can eat orally. (7)The patients who can start treatment within 4 to 12 weeks after surgery. (8)The patients who obtained the written consent before performing the various procedures for the test. Patients who can understand and are willing to sign the contents of the consent document.
Key exclusion criteria (1)Patients who could not resected curatively.(2)Patients with active double cancer. (3)Patients with serious drug hypersensitivity or with a history of drug allergy.(4)Patients with serious complications.(5)Patients with jaundice,cirrhosis or with suspected cirrhosis of the liver.(6)There is a history of chronic hepatitis B, and in the present study drug has already been ingested.(7)Patients with active infection.(8)Women who have a possibility of or in the pregnancy,who hope to become pregnant,or who are breast-feeding. Men who wish to become pregnant partner.(9)Patients with severe mental disorder.(10)Other patients whom the physician decided to be unsuitable for safely carrying out the present study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University,Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2,Yamadaoka,Suita City, Osaka
TEL 0668793251
Email heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University,Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2,Yamadaoka,Suita City, Osaka
TEL 0668793251
Homepage URL
Email heguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization National Institute of Public Health
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 05 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 No longer recruiting
Date of protocol fixation
2015 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 14 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
2017 Year 05 Month 22 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031431

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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