Pancreatin ( DrugBank: Pancreatin )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
298遺伝性膵炎5
299嚢胞性線維症23

298. 遺伝性膵炎


臨床試験数 : 95 薬物数 : 148 - (DrugBank : 51) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05261997
(ClinicalTrials.gov)
March 202224/11/2021Endotherapy for Painless Chronic PancreatitisEffect of Endotherapy on the Progression of Chronic Pancreatitis in Painless PatientsPancreatitis, Chronic;Exocrine Pancreatic Insufficiency;Abdominal Pain;Cholangiopancreatography, Endoscopic RetrogradeProcedure: extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct;Drug: pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets)Changhai HospitalNULLRecruiting18 Years70 YearsAll60N/AChina
2EUCTR2005-000562-38-DE
(EUCTR)
20/04/201029/09/2005RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002 The purpose of this trial is to evaluate the clinical efficacy and safety of a gastro-resistant film-coated tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 7.0;Level: LLT;Classification code 10033628
Trade Name: Mezym F
Product Name: Mezym F
Product Code: Pancreatin
INN or Proposed INN: Pancreatin
Berlin-Chemie AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Germany
3NCT00705978
(ClinicalTrials.gov)
June 200826/6/2008Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic PancreatitisA One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term ExtensionPancreatic InsufficiencyDrug: Pancreatin;Drug: PlaceboAbbott ProductsQuintiles, DatamapCompleted18 YearsN/ABoth62Phase 3India
4EUCTR2005-000736-24-DE
(EUCTR)
14/07/200513/05/2005RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003 The purpose of this trial is to evaluate the clinical efficacy and safety of an enteric-coated pancreatin tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis.
MedDRA version: 7.0;Level: LLT;Classification code 10033628
Trade Name: Helopanflat Mono®
Product Name: Helopanflat Mono®
Product Code: Pancreatin
INN or Proposed INN: Pancreatin
Berlin-Chemie AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Germany
5EUCTR2004-002468-89-DE
(EUCTR)
28/10/200423/09/2004A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine InsufficiencyA RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency The purpose of this clinical trial is to evaluate the clinical efficacy and safety of a capsule containing enteric-coated porcine pancreatin microfilm tablets in comparison with placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis.
MedDRA version: 7.0;Level: LLT;Classification code 10033622
Trade Name: Panzytrat 25.000
Product Name: Panzytrat 25.000
Product Code: Pancreatin
INN or Proposed INN: Pancreatin
Axcan Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Germany

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004940-31-DK
(EUCTR)
24/03/202024/03/2020Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trialEffect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency
MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Creon 10.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Trade Name: Creon 25.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Trade Name: Creon 40.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Terese KatzensteinNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Denmark
2EUCTR2017-000571-85-GB
(EUCTR)
19/09/201711/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom
3EUCTR2017-000571-85-LT
(EUCTR)
15/09/201720/07/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
4EUCTR2017-000571-85-HU
(EUCTR)
15/06/201713/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
5EUCTR2017-000571-85-ES
(EUCTR)
01/06/201721/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
6EUCTR2015-002739-17-CZ
(EUCTR)
09/03/201613/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Hungary;Czech Republic;Canada;Spain;Israel
7EUCTR2015-002739-17-HU
(EUCTR)
30/12/201513/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
8EUCTR2015-002739-17-ES
(EUCTR)
16/12/201503/11/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
9EUCTR2014-004519-35-GB
(EUCTR)
23/02/201508/12/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
10EUCTR2014-004519-35-CZ
(EUCTR)
18/02/201519/11/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Hungary;Czech Republic;Spain;United Kingdom
11EUCTR2014-004519-35-ES
(EUCTR)
30/01/201504/12/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: KREON de Liberación Inmediata
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATINA (Páncreas Polvo
Trade Name: Kreon 25 000
Product Name: Kreon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA (Páncreas Polvo)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
12EUCTR2014-004519-35-HU
(EUCTR)
09/01/201512/11/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (Pancreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
13EUCTR2013-002819-10-ES
(EUCTR)
26/12/201312/11/2013A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: KREON N 25000
INN or Proposed INN: Not applicable
Other descriptive name: PANCREATIN
Trade Name: Kreon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
14EUCTR2013-002819-10-HU
(EUCTR)
29/11/201314/10/2013A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON N 25000
INN or Proposed INN: not applicable
Other descriptive name: PANCREATIN
Trade Name: Creon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
15EUCTR2009-012842-21-HU
(EUCTR)
27/06/201310/05/2013Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
16EUCTR2009-012842-21-BE
(EUCTR)
19/11/201214/05/2012Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
17NCT01747330
(ClinicalTrials.gov)
June 201223/11/2012Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine InsufficiencyAn Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisPancreatic Exocrine InsufficiencyDrug: PancreatinAbbott ProductsNULLCompletedN/A4 YearsAll40Phase 3Russian Federation
18EUCTR2009-012842-21-BG
(EUCTR)
24/02/201128/09/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy
19EUCTR2009-012842-21-DE
(EUCTR)
13/01/201113/07/2010Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
20EUCTR2009-012842-21-GB
(EUCTR)
20/09/201017/06/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
21EUCTR2017-000571-85-PL
(EUCTR)
08/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom
22EUCTR2005-001438-34-BE
(EUCTR)
15/07/2005A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionA Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionTrade Name: Panzytrat® ok
Product Name: Pancrelipase Microtablets
Product Code: N/A
INN or Proposed INN: Pancreatin
McNeil Consumer and Specialty PharmaceuticalsNULLNAFemale: yes
Male: yes
20Phase 2Belgium
23EUCTR2010-019267-11-DE
(EUCTR)
19/10/2010AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: LLT;Classification code 10041968;Term: Steatorrhea;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: PANZYTRAT 25000
Product Name: PANZYTRAT 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: KREON 25000
Product Name: KREON 25000
Other descriptive name: PANCREATIN
Axcan Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
68Germany