Pancrelipase Delayed Release Capsule ( DrugBank: Pancrelipase )


2 diseases
IDDisease name (Link within this page)Number of trials
298Hereditary pancreatitis2
299Cystic fibrosis2

298. Hereditary pancreatitis


Clinical trials : 98 Drugs : 180 - (DrugBank : 57) / Drug target genes : 53 - Drug target pathways : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-004004-12-BG
(EUCTR)
28/02/200805/02/2008A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMYA STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy
Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
52Bulgaria
2NCT00414908
(ClinicalTrials.gov)
October 200721/12/2006A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and PancreatectomyA Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and PancreatectomyChronic Pancreatitis;Pancreatectomy;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase delayed release capsule;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted18 YearsN/AAll52Phase 3United States;Bulgaria;Poland;Puerto Rico;Russian Federation;Serbia;South Africa;Ukraine;Former Serbia and Montenegro

299. Cystic fibrosis


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00775528
(ClinicalTrials.gov)
April 200917/10/2008Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisAn Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisCystic Fibrosis;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase Delayed ReleaseSolvay PharmaceuticalsNULLCompleted1 Month6 YearsAll19Phase 3United States
2EUCTR2007-004004-12-BG
(EUCTR)
28/02/200805/02/2008A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMYA STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy
Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
52Bulgaria