The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy
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|ClinicalTrials.gov Identifier: NCT02127021|
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreaticoduodenectomy||Drug: Norzyme® 40000 IU Drug: Placebo||Phase 4|
There are not enough studies evaluating nutritional parameters in patients with pancreatic resection. After pancreatic surgery, there are several ways to improve patient condition in terms of quality of life including nutrition.
In the investigators previous study, pancreatic enzyme supplement through the administration of Norzyme® 25000 IU containing lipase 25000 IU, amylase 22500 IU, and protease 1250 IU after various type of pancreatectomy to improve quality of life and nutritional status failed to prove its effectiveness. After administration of low-dose Norzyme® (25000 IU), some patients showed weight gain, but statistically significant conclusions were not obtained mainly because of various types of pancreatectomy and low supplementary dosage of pancreatic enzyme.
Therefore, the investigators design this study to find out the effect of high-dose Norzyme® (40000 IU) on weight gain, quality of life, stool habit change, and nutritional status in patients with pancreaticoduodenectomy. The investigators will evaluate the effectiveness and adequacy of high-dose pancreatic supplementary treatment through a randomized, placebo-using, single-blinded, and multicenter study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prospective Study for the Effects of High Dose Pancreatic Enzyme Replacement Therapy on Body Weight, Quality of Life, and Nutritional Assessment After Pancreatoduodenectomy|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||September 7, 2017|
|Actual Study Completion Date :||December 31, 2017|
Experimental: Norzyme® 40000 IU
Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.
Drug: Norzyme® 40000 IU
A kind of pancreatic enzyme supplement containing lipase: 40,000 FIP, amylase: 25,000 FIP, and protease: 1,500 FIP Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal
Other Name: Norzyme
Placebo Comparator: Placebo
Single capsule of placebo drug with the same appearance of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal. The formulation and the form of placebo is same with the Norzyme® 40000 IU. Placebo contains microcrystalline cellulose as the main component, titanium oxide, colloidal silica, yellow iron oxide, brown iron oxide, black iron oxide, magnesium stearate, triethyl citrate, talc, and simethicone emulsion in very small amount
Single capsule of placebo drug with the same appearance of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.
- Change from Baseline in body weight at 3 months after medication [ Time Frame: 3 months after medication ]Body weight will be measured 3 times during the entire study period, once preoperatively and two times postoperatively. After surgery, weight will be measured before medication and at the 3 months after medication.These serial weight measurements will be analyzed to figure out changes in body weight over time.
- Change from Baseline in Nutritional Status at 3 months after medication [ Time Frame: 3 months after medication ]To assess the nutritional status of the patient underwent pancreaticoduodenectomy by testing fasting blood glucose, C-peptide, Insulin, Hb A1c, serum protein, serum albumin, serum pre-albumin, and transferrin
- Change from baseline in stool habit at 3 months after medication [ Time Frame: 3 months after medication ]To check change from baseline in stool habit at 3 months after medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127021
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Bundang-gu, Korea, Republic of, 463-707|
|Center for Liver Cancer, National Cancer Center|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Dongguk University Ilsan Medical Center|
|Goyang, Kyeonggi, Korea, Republic of, 410-773|
|Department of Surgery, Seoul National University College of Medicine|
|Seoul, Korea, Republic of, 110-744|
|Chung-Ang University Hospital|
|Seoul, Korea, Republic of, 156-755|
|Kangnam Severance Hospital|
|Seoul, Korea, Republic of|
|Study Chair:||Jin-Young Jang, M.D., PhD.||Seoul National University Hospital|
|Principal Investigator:||Jin-Young Jang, M.D., PhD.||Seoul National University Hospital|