299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05069597 (ClinicalTrials.gov) | October 14, 2021 | 27/9/2021 | Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon | A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient | Cystic Fibrosis;Chronic Pancreatitis | Drug: CREON | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 2 | EUCTR2019-004940-31-DK (EUCTR) | 24/03/2020 | 24/03/2020 | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | Effect 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 Katzenstein | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 3 | NCT03924947 (ClinicalTrials.gov) | November 6, 2019 | 18/4/2019 | A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | NULL | Completed | 12 Years | N/A | All | 36 | Phase 4 | United States;Spain |
| 4 | EUCTR2017-000571-85-GB (EUCTR) | 19/09/2017 | 11/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom | ||
| 5 | EUCTR2017-000571-85-LT (EUCTR) | 15/09/2017 | 20/07/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 6 | EUCTR2017-000571-85-HU (EUCTR) | 15/06/2017 | 13/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 7 | EUCTR2017-000571-85-ES (EUCTR) | 01/06/2017 | 21/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 8 | EUCTR2015-002739-17-CZ (EUCTR) | 09/03/2016 | 13/10/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Czech Republic;Canada;Spain;Israel | ||
| 9 | EUCTR2015-002739-17-HU (EUCTR) | 30/12/2015 | 13/10/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Israel | ||
| 10 | EUCTR2015-002739-17-ES (EUCTR) | 16/12/2015 | 03/11/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Israel | ||
| 11 | EUCTR2014-004519-35-GB (EUCTR) | 23/02/2015 | 08/12/2014 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 12 | EUCTR2014-004519-35-CZ (EUCTR) | 18/02/2015 | 19/11/2014 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Hungary;Czech Republic;Spain;United Kingdom | ||
| 13 | EUCTR2014-004519-35-ES (EUCTR) | 30/01/2015 | 04/12/2014 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 14 | EUCTR2014-004519-35-HU (EUCTR) | 09/01/2015 | 12/11/2014 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 15 | NCT02372383 (ClinicalTrials.gov) | October 2014 | 20/6/2014 | Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis | Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls | Cystic Fibrosis | Drug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: Pancrelipase | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences Institute | Completed | 16 Years | 45 Years | Both | 32 | N/A | United States |
| 16 | EUCTR2013-002819-10-ES (EUCTR) | 26/12/2013 | 12/11/2013 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 17 | EUCTR2013-002819-10-HU (EUCTR) | 29/11/2013 | 14/10/2013 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 18 | EUCTR2009-012842-21-HU (EUCTR) | 27/06/2013 | 10/05/2013 | Treatment 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: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 19 | EUCTR2009-012842-21-BE (EUCTR) | 19/11/2012 | 14/05/2012 | Treatment 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. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 3 | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 20 | NCT01747330 (ClinicalTrials.gov) | June 2012 | 23/11/2012 | Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency | An 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 Fibrosis | Pancreatic Exocrine Insufficiency | Drug: Pancreatin | Abbott Products | NULL | Completed | N/A | 4 Years | All | 40 | Phase 3 | Russian Federation |
| 21 | EUCTR2009-012842-21-BG (EUCTR) | 24/02/2011 | 28/09/2010 | Treatment 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: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy | |||
| 22 | EUCTR2009-012842-21-DE (EUCTR) | 13/01/2011 | 13/07/2010 | Treatment 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 Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 23 | EUCTR2009-012842-21-GB (EUCTR) | 20/09/2010 | 17/06/2010 | Treatment 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. | NULL | Not 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): no | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 24 | NCT00775528 (ClinicalTrials.gov) | April 2009 | 17/10/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | An 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 Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release | Solvay Pharmaceuticals | NULL | Completed | 1 Month | 6 Years | All | 19 | Phase 3 | United States |
| 25 | NCT00744250 (ClinicalTrials.gov) | August 2008 | 28/8/2008 | Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control | Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic Fibrosis | Drug: Pancrelipase | Digestive Care, Inc. | University of North Carolina, Chapel Hill | Terminated | 18 Years | N/A | Both | 3 | Phase 4 | United States |
| 26 | NCT00662675 (ClinicalTrials.gov) | August 2008 | 17/4/2008 | A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic Fibrosis | Drug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 7 Years | 60 Years | All | 40 | Phase 3 | United States;Canada |
| 27 | NCT00690820 (ClinicalTrials.gov) | June 2008 | 3/6/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 7 Years | 11 Years | All | 17 | Phase 3 | United States |
| 28 | EUCTR2007-004004-12-BG (EUCTR) | 28/02/2008 | 05/02/2008 | A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 52 | Bulgaria | |||
| 29 | NCT00510484 (ClinicalTrials.gov) | November 2007 | 1/8/2007 | Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 35 | Phase 3 | United States;Hungary;Israel;South Africa;Spain |
| 30 | NCT00432861 (ClinicalTrials.gov) | January 2007 | 7/2/2007 | Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Crossover Study to Evaluate the Effectiveness and Safety of PANCRECARB® MS-16 (Pancrelipase) in Reducing Steatorrhea in Children and Adults With Cystic Fibrosis | Cystic Fibrosis;Pancreatic Insufficiency | Drug: PANCRECARB® (pancrelipase);Drug: Placebo | Digestive Care, Inc. | NULL | Completed | 7 Years | N/A | Both | 29 | Phase 3 | United States |
| 31 | NCT00217204 (ClinicalTrials.gov) | July 2005 | 13/9/2005 | An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Cystic Fibrosis;Steatorrhea | Drug: Pancrelipase microtablets | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | NULL | Completed | 6 Months | 30 Months | Both | 18 | Phase 2 | Belgium;Netherlands |
| 32 | NCT00006063 (ClinicalTrials.gov) | July 1999 | 5/7/2000 | Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pancrelipase with bicarbonate | National Center for Research Resources (NCRR) | Indiana University School of Medicine | Completed | N/A | N/A | Both | 24 | N/A | NULL | |
| 33 | EUCTR2010-019267-11-DE (EUCTR) | 19/10/2010 | 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) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Germany | ||||
| 34 | EUCTR2005-001438-34-BE (EUCTR) | 15/07/2005 | A 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 | A 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 Malabsorption | Trade Name: Panzytrat® ok Product Name: Pancrelipase Microtablets Product Code: N/A INN or Proposed INN: Pancreatin | McNeil Consumer and Specialty Pharmaceuticals | NULL | NA | Female: yes Male: yes | 20 | Phase 2 | Belgium | |||
| 35 | EUCTR2015-001219-11-Outside-EU/EEA (EUCTR) | 31/03/2015 | A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiency | A randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency | Cystic fibrosis MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: PANCREASE MT Product Name: PANCREASE MT INN or Proposed INN: pancrelipase Other descriptive name: PANCRELIPASE AMYLASE | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | NULL | NA | Female: yes Male: yes | 40 | Phase 3 | United States;Canada | |||
| 36 | EUCTR2017-000571-85-PL (EUCTR) | 08/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom |