Lipase (DrugBank: -)
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 | 12 |
| 299 | 嚢胞性線維症 | 20 |
| 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 | NCT03481803 (ClinicalTrials.gov) | January 27, 2017 | 6/3/2018 | A Phase IIa Study With Escalating Dose of MS1819-SD | A Multicentre Open-label Phase IIa Study With Escalating Dose of MS1819- SD, to Investigate the Efficacy and Safety of a Yarrowia Lipolytica Lipase Preparation for the Compensation of Exocrine Pancreatic Insufficiency Caused by Chronic Pancreatitis and/or Distal Pancreatectomy | Chronic Pancreatitis;Distal Pancreatectomy | Drug: MS1819-SD | AzurRx SAS | NULL | Completed | 18 Years | N/A | All | 11 | Phase 2 | Australia;France;New Zealand |
| 2 | NCT01430234 (ClinicalTrials.gov) | October 2011 | 1/9/2011 | Enzyme Suppletion in Exocrine Pancreatic Dysfunction | Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen | Chronic Pancreatitis;Exocrine Pancreatic Insufficiency | Drug: Panzytrat 25.000 FIP-E units of Lipase | Foundation for Liver Research | Axcan Pharma | Completed | 18 Years | 90 Years | Both | 10 | Phase 4 | Netherlands |
| 3 | EUCTR2010-020303-69-NL (EUCTR) | 19/09/2011 | 19/09/2011 | Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES | Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES | Exocrine pancreatic insufficiency in patients with chronic pancreatitis MedDRA version: 12.1;Level: LLT;Classification code 10041969;Term: Steatorrhoea | Trade Name: Panzytrat Product Name: Panzytrat Product Code: RVG 13760 INN or Proposed INN: pancreatic enzymes Other descriptive name: LIPASE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Netherlands | |||
| 4 | EUCTR2010-018900-10-FR (EUCTR) | 11/05/2010 | 19/03/2010 | Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis | Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis | Exocrine pancreatic insufficiency resulting from chronic pancreatitis MedDRA version: 12.1;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency | Product Name: MS1819 Product Code: MS1819 INN or Proposed INN: Yarrowia lipolytica lipase | Laboratoires Mayoly Spindler | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | France | |||
| 5 | EUCTR2007-000375-42-HU (EUCTR) | 07/04/2008 | 14/12/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 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 |
| 6 | EUCTR2008-000061-37-IT (EUCTR) | 02/04/2008 | 08/05/2008 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002 | Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI) MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders | Product Name: ZENTASE INN or Proposed INN: Multienzymes (lipase, protease etc.) | EURAND SPA | NULL | Not Recruiting | Female: yes Male: yes | 72 | Italy | |||
| 7 | NCT00559052 (ClinicalTrials.gov) | March 2008 | 14/11/2007 | An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI) | An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI). | Exocrine Pancreatic Insufficiency | Drug: VIOKASE 16 | Axcan Pharma | AAIPharma;Mayo Clinical Services;City Hospital Laboratory Birmingham | Completed | 18 Years | N/A | Both | 22 | Phase 2 | United States;Czech Republic |
| 8 | EUCTR2007-000375-42-DK (EUCTR) | 21/02/2008 | 23/10/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 9 | EUCTR2007-000375-42-CZ (EUCTR) | 08/02/2008 | 17/12/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 10 | EUCTR2007-000375-42-LV (EUCTR) | 05/02/2008 | 12/02/2008 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 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 |
| 11 | NCT00630279 (ClinicalTrials.gov) | February 2008 | 22/2/2008 | Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | A Multi-center, Single-blind, Parallel-design, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate Oral Recombinant Microbial Lipase Efficacy in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | Drug: Placebo;Drug: Recombinant Microbial Lipase SLV339 | Solvay Pharmaceuticals | NULL | Terminated | 18 Years | N/A | Both | 56 | Phase 2 | Czech Republic;Denmark;Hungary;Latvia;Poland;Russian Federation;Sweden |
| 12 | EUCTR2007-000375-42-SE (EUCTR) | 21/12/2007 | 26/10/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | EUCTR2016-002851-92-CZ (EUCTR) | 05/10/2016 | 02/08/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;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 | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Israel | ||
| 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 |
| 6 | EUCTR2016-002851-92-HU (EUCTR) | 08/09/2016 | 25/07/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;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 | ANTHERA Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Hungary;Canada;Spain;Israel | ||
| 7 | NCT02750501 (ClinicalTrials.gov) | July 20, 2016 | 20/4/2016 | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding | Cystic Fibrosis | Device: RELiZORB (immobilized lipase) cartridge;Other: Impact Peptide 1.5 | Alcresta Therapeutics, Inc. | Cystic Fibrosis Foundation | Completed | 4 Years | N/A | All | 49 | N/A | United States |
| 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 | ||
| 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 |
| 11 | EUCTR2009-012842-21-IT (EUCTR) | 10/08/2010 | 23/08/2010 | A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND | A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND | exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) MedDRA version: 9.1;Level: HLGT;Classification code 10015674 MedDRA version: 9.1;Level: LLT;Classification code 10011762 | Trade Name: ZENPEP INN or Proposed INN: Multienzymes (lipase, protease etc.) Trade Name: CREON 10000 Capsules INN or Proposed INN: Multienzymes (lipase, protease etc.) | EURAND SPA | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;United Kingdom;Italy | |||
| 12 | EUCTR2007-000178-21-IT (EUCTR) | 31/12/2007 | 07/01/2008 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) | ALTUS PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 200 | Italy | |||
| 13 | EUCTR2007-000171-41-IT (EUCTR) | 31/12/2007 | 07/01/2008 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTUS-135 Product Code: ALTUS-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) | ALTUS PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | Italy | ||
| 14 | EUCTR2007-000171-41-SK (EUCTR) | 16/07/2007 | 10/04/2008 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Italy | ||
| 15 | EUCTR2007-000178-21-SK (EUCTR) | 16/07/2007 | 10/04/2008 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Italy | ||
| 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 |
| 16 | EUCTR2006-005180-25-DE (EUCTR) | 15/12/2006 | 31/10/2006 | A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design | A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design | Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study. MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Code: LU 70274 | Nordmark Arzneimittel GmbH | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 17 | EUCTR2007-000178-21-PL (EUCTR) | 04/09/2007 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Poland;Italy | |||
| 18 | EUCTR2007-000171-41-PL (EUCTR) | 11/07/2007 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc | NULL | NA | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Poland;Italy | |||
| 19 | 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 | |||
| 20 | EUCTR2016-002851-92-PL (EUCTR) | 02/08/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;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 | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Poland;Israel |