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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009912
Receipt No. R000011497
Scientific Title Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency in patients with unresectable pancreatic cancer.
Date of disclosure of the study information 2013/01/31
Last modified on 2016/04/12

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Basic information
Public title Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Acronym Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Scientific Title Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Scientific Title:Acronym Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency in patients with unresectable pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in body weight from baseline to 3 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of pancrelipase (1800mg/day for 3 months)
Interventions/Control_2 Oral administration of pancreatin (3000mg/day for 3 months)
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 cytologically or histologically proven, unresectable adenocarcinoma of the pancreas
(2)Age >= 20 years
(3)ECOG Performance status of 0-1
(4)Written informed consent
(5)Estimated prognosis >= 3 months
(6)adequate oral intake
(7)adequate organ function
Key exclusion criteria (1)Gastrointestinal obstruction
(2)Severe concurrent disease
(3)Pregnant or lactating women
(4)Hypersensitivity to porcine or bovine protein, or severe drug hypersensitibity
(5)History of gastrointestinal tract surgery
(6)Prior chemotherapy or radiotherapy
(7)Mental disorder
(8)Inadequate physical condition
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taketo Yamaguchi
Organization Chiba Cancer Center
Division name Gastroenterology
Zip code
Address 666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba Cancer Center
Division name Gastroenterology
Zip code
Address
TEL 043-264-5431
Homepage URL
Email

Sponsor
Institute Chiba Cancer Center
Institute
Department

Funding Source
Organization None
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 01 Month 31 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
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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 01 Month 30 Day
Last modified on
2016 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011497

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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