CREON ( 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9
299嚢胞性線維症16

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
1NCT05069597
(ClinicalTrials.gov)
October 14, 202127/9/2021Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With CreonA 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 IngredientCystic Fibrosis;Chronic PancreatitisDrug: CREONAbbVieNULLRecruiting18 YearsN/AAll30Phase 4United States
2NCT04949828
(ClinicalTrials.gov)
September 16, 202121/6/2021Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) SymptomsObservational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)Chronic PancreatitisDrug: CREONAbbVieNULLRecruiting18 YearsN/AAll90United States
3NCT04315311
(ClinicalTrials.gov)
May 6, 202018/3/2020Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerA Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerExocrine Pancreatic Insufficiency (EPI)Drug: CREONAbbVieNULLWithdrawn18 YearsN/AAll0Phase 4United States
4NCT02849704
(ClinicalTrials.gov)
October 13, 201627/7/2016Fat Malabsorption in Chronic PancreatitisDiagnosing Pancreatic-Based Malabsorption in Patients With Chronic PancreatitisChronic PancreatitisDrug: Creon36™Children's Hospital of PhiladelphiaAbbVie;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Phoenix Indian Medical CenterCompleted30 Years70 YearsAll48Phase 2United States
5EUCTR2015-002570-20-ES
(EUCTR)
25/02/201618/04/2016Optimizing treatment of maldigestion in patients with chronic pancreatitisOpen 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 SantiagoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
6NCT00705978
(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
7EUCTR2007-004004-12-BG
(EUCTR)
28/02/200805/02/2008A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMYA STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy
Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
52Bulgaria
8NCT01154608
(ClinicalTrials.gov)
April 200530/6/2010Effect of Enzyme Therapy on Protein Metabolism in Chronic PancreatitisPancreatitisDrug: Creon;Other: No enzyme therapyInstitut National de la Recherche AgronomiqueNational Research Agency, France;Solvay PharmaceuticalsCompleted18 YearsN/ABoth11N/AFrance
9NCT00957151
(ClinicalTrials.gov)
April 200411/8/2009Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic PancreatitisEvaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic PancreatitisChronic PancreatitisDrug: CreonHospital AvicenneSolvay PharmaceuticalsCompleted18 Years65 YearsBoth12Phase 4France

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
1NCT05069597
(ClinicalTrials.gov)
October 14, 202127/9/2021Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With CreonA 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 IngredientCystic Fibrosis;Chronic PancreatitisDrug: CREONAbbVieNULLRecruiting18 YearsN/AAll30Phase 4United States
2NCT04315311
(ClinicalTrials.gov)
May 6, 202018/3/2020Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerA Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerExocrine Pancreatic Insufficiency (EPI)Drug: CREONAbbVieNULLWithdrawn18 YearsN/AAll0Phase 4United States
3EUCTR2019-004940-31-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
4NCT03924947
(ClinicalTrials.gov)
November 6, 201918/4/2019A 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 FibrosisA 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 FibrosisCystic FibrosisDrug: PancrelipaseAbbVieNULLCompleted12 YearsN/AAll36Phase 4United States;Spain
5NCT02415959
(ClinicalTrials.gov)
March 201519/3/2015Efficacy and Safety Study 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 FibrosisExocrine Pancreatic Insufficiency in Subjects With Cystic FibrosisDrug: Creon IR;Drug: Creon® (DR/GR)AbbottAbbVie;LKF Laboratorium für Klinische Forschung GmbH;Analytical Biochemical Laboratory;Parexel;Datamap;Linical Co., Ltd.Completed12 YearsN/AAll70Phase 2Czech Republic;Hungary;Poland;Spain
6EUCTR2014-004519-35-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
7EUCTR2014-004519-35-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
8EUCTR2014-004519-35-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
9EUCTR2014-004519-35-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
10NCT02137382
(ClinicalTrials.gov)
January 201412/2/2014A 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 FibrosisPancreatic Exocrine Insufficiency Due to Cystic FibrosisDrug: Creon®;Drug: Creon NAbbottNULLCompleted12 YearsN/AAll41Phase 3Hungary;Spain;Russian Federation
11EUCTR2013-002819-10-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
12EUCTR2013-002819-10-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
13NCT01652157
(ClinicalTrials.gov)
July 31, 201225/7/2012Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)Fibrosing ColonopathyBiological: ULTRESA;Biological: PANCREAZE;Biological: CREON;Biological: ZENPEP;Biological: other non-sponsor pancreatic enzyme replacement therapy;Biological: PERTZYE;Other: No pancreatic enzyme replacement therapyAbbVieCystic Fibrosis Foundation;Digestive Care, Inc.;Nestle Health Science;VIVUS, Inc.TerminatedN/A99 YearsAll17United States
14NCT01747330
(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
15EUCTR2009-012842-21-IT
(EUCTR)
10/08/201023/08/2010A 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 - NDA 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 SPANULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;United Kingdom;Italy
16EUCTR2007-004004-12-BG
(EUCTR)
28/02/200805/02/2008A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMYA STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy
Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
52Bulgaria