Unique ID issued by UMIN | UMIN000009912 |
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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 |
Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency
in patients with unresectable pancreatic cancer.
Japan |
pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To assess the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency in patients with unresectable pancreatic cancer.
Efficacy
The change in body weight from baseline to 3 months
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Oral administration of pancrelipase (1800mg/day for 3 months)
Oral administration of pancreatin (3000mg/day for 3 months)
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
80
1st name | |
Middle name | |
Last name | Taketo Yamaguchi |
Chiba Cancer Center
Gastroenterology
666-2 Nitona-cho, Chuo-ku, Chiba, Japan
1st name | |
Middle name | |
Last name |
Chiba Cancer Center
Gastroenterology
043-264-5431
Chiba Cancer Center
None
Self funding
NO
2013 | Year | 01 | Month | 31 | Day |
Unpublished
Terminated
2012 | Year | 03 | Month | 15 | Day |
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 01 | Month | 30 | Day |
2016 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011497
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