298. 遺伝性膵炎 Hereditary pancreatitis Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 180 - (DrugBank : 57) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
| 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 | EUCTR2015-002570-20-ES (EUCTR) | 25/02/2016 | 18/04/2016 | Optimizing treatment of maldigestion in patients with chronic pancreatitis | Open label, randomized, crossover clinical trial to evaluate the efficacy of increasing doses of pancreatic enzymes against inhibition of acid gastric secretion in patients with exocrine pancreatic insufficiency secondary to chronic pancreatitis | Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25000 Product Name: Creon 25000 Product Code: PL 00512/0150 | Department of gastroenterology. University Hospital of Santiago | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 3 | NCT02693093 (ClinicalTrials.gov) | December 2015 | 12/2/2016 | A Dose Ranging Study Evaluating Efficacy and Safety of NI-03 | A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis | Chronic Pancreatitis | Drug: NI-03;Drug: Placebo | Kangen Pharmaceuticals, Inc | NULL | Active, not recruiting | 18 Years | 85 Years | All | 260 | Phase 1/Phase 2 | United States;Russian Federation;Ukraine |
| 4 | NCT02567240 (ClinicalTrials.gov) | January 2015 | 1/10/2015 | Carbon Monoxide-Saturated Medium for Islet Isolation | A Novel Approach to Harvest Islets for Autologous Islet Transplantation | Chronic Pancreatitis | Other: Carbon monoxide-bubbled mediums | Medical University of South Carolina | NULL | Completed | 18 Years | 69 Years | All | 16 | Phase 1/Phase 2 | United States |
| 5 | NCT02384018 (ClinicalTrials.gov) | December 2014 | 16/12/2014 | Mesenchymal Stem Cell and Islet Co-transplantation | A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow-derived Mesenchymal Stromal Cells in Chronic Pancreatitis Patients Who Undergo Total Pancreatectomy and Islet Autotransplantation. | Chronic Pancreatitis;Diabetes | Biological: autologous mesenchymal stromal cell | Medical University of South Carolina | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active, not recruiting | 18 Years | 69 Years | All | 24 | Phase 1 | United States |
| 6 | NCT01967888 (ClinicalTrials.gov) | February 2014 | 18/10/2013 | Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation | Pancreatectomy for Chronic Pancreatitis | Drug: Reparixin;Drug: Placebo | Dompé Farmaceutici S.p.A | NULL | Completed | 18 Years | N/A | All | 104 | Phase 2/Phase 3 | United States;Canada |
| 7 | NCT01318369 (ClinicalTrials.gov) | October 2011 | 9/3/2011 | Efficacy Study of ?9-THC to Treat Chronic Abdominal Pain | The Safety, Tolerability, and Analgesic Efficacy of ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain | Cannabinoid;Tetrahydrocannabinol;Chronic Pancreatitis;Abdominal Pain | Drug: Namisol;Drug: Diazepam | Radboud University | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 2 | Netherlands |
| 8 | 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 | |||
| 9 | EUCTR2011-000647-24-NL (EUCTR) | 26/07/2011 | 12/05/2011 | Efficacy study of ?9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammation | The safety, tolerability, and analgesic efficacy of ?9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain - ?9-THC in chronic pain | patients with abdominal pain as a result of chronic pancreatitis MedDRA version: 13.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Namisol Product Code: A04AD10 INN or Proposed INN: DRONABINOL | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: no Male: yes | Netherlands | ||||
| 10 | NCT01146561 (ClinicalTrials.gov) | October 13, 2010 | 24/5/2010 | Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS | Chronic Pancreatitis | Biological: Tanezumab;Other: Placebo | Pfizer | NULL | Terminated | 18 Years | 99 Years | All | 2 | Phase 2 | United States |
| 11 | NCT01159119 (ClinicalTrials.gov) | August 2, 2010 | 5/7/2010 | A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain | Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain | Chronic Pancreatitis | Drug: EUR-1066-A;Drug: Zenpep;Drug: EUR-1066-B | Forest Laboratories | University of Florida | Terminated | 18 Years | N/A | All | 15 | Phase 1 | United States |
| 12 | 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 | |||
| 13 | EUCTR2005-000562-38-DE (EUCTR) | 20/04/2010 | 29/09/2005 | RANDOMISED, 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 | RANDOMISED, 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Germany | ||
| 14 | NCT01001923 (ClinicalTrials.gov) | December 2009 | 26/10/2009 | Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain | Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis | Abdominal Pain Upper | Drug: REGN475/SAR164877;Drug: Placebo (for REGN475/SAR164877) | Regeneron Pharmaceuticals | NULL | Terminated | 18 Years | 80 Years | Both | 15 | Phase 2 | United States |
| 15 | NCT00401076 (ClinicalTrials.gov) | July 2008 | 16/11/2006 | A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency | A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy | Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy | Drug: SA-001 | Abbott | NULL | Completed | 20 Years | N/A | Both | 80 | Phase 3 | Japan |
| 16 | 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 | |||
| 17 | NCT00788593 (ClinicalTrials.gov) | January 2008 | 10/11/2008 | A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) | A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 in Chronic Pancreatitis (CP) Patients With Exocrine Pancreatic Insufficiency (EPI) | Chronic Pancreatitis;Exocrine Pancreatic Insufficiency | Drug: Placebo;Drug: EUR-1008 (APT-1008) High Dose;Drug: EUR-1008 (APT-1008) Low Dose | Forest Laboratories | NULL | Completed | 18 Years | N/A | All | 82 | Phase 3 | United States;Italy;Ukraine |
| 18 | NCT00500084 (ClinicalTrials.gov) | December 2007 | 10/7/2007 | Phase III ALTU-135 CP Safety Trial | An Open-Label Clinical Study Evaluating the Long Term Safety of ALTU-135 in the Treatment of Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy | Exocrine Pancreatic Insufficiency | Drug: Liprotamase | Anthera Pharmaceuticals | NULL | Terminated | 18 Years | N/A | Both | 39 | Phase 3 | United States |
| 19 | NCT00559364 (ClinicalTrials.gov) | November 2007 | 14/11/2007 | Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea | A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Pancreatectomy | Drug: Viokase® 16;Drug: Placebo;Drug: Proton pump inhibitor (PPI);Drug: Omeprazole | Forest Laboratories | NULL | Completed | 18 Years | 80 Years | All | 50 | Phase 3 | United States;Canada;Poland;Slovakia;Germany |
| 20 | NCT00400842 (ClinicalTrials.gov) | May 2007 | 16/11/2006 | A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency | A Double-blind, Placebo-controlled, Parallel-group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy | Exocrine Pancreatic Insufficiency, Chronic Pancreatitis | Drug: SA-001;Drug: Placebo | Abbott | NULL | Completed | 20 Years | N/A | Both | 274 | Phase 3 | Japan |
| 21 | NCT00469703 (ClinicalTrials.gov) | August 2005 | 3/5/2007 | Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis | A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis. | Chronic Pancreatitis | Drug: Thalidomide | Winthrop University Hospital | Celgene Corporation | Terminated | 18 Years | 75 Years | Both | 10 | Phase 2 | United States |
| 22 | EUCTR2005-000736-24-DE (EUCTR) | 14/07/2005 | 13/05/2005 | RANDOMISED, 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 | RANDOMISED, 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Germany | ||
| 23 | EUCTR2004-002468-89-DE (EUCTR) | 28/10/2004 | 23/09/2004 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Germany |