UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009912
Receipt number 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 19:53:28

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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 or person

Institute

Chiba Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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