299. 嚢胞性線維症
[臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
34 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004940-31-DK
(EUCTR)
24/03/202024/03/2020Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trialEffect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency
MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Creon 10.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Trade Name: Creon 25.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Trade Name: Creon 40.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Terese KatzensteinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Denmark
2NCT03924947
(ClinicalTrials.gov)
October 23, 201918/4/2019A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing 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, in Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Cystic FibrosisCystic FibrosisDrug: PancrelipaseAbbVieNULLRecruiting12 YearsN/AAll28Phase 4United States;Spain
3EUCTR2017-000571-85-GB
(EUCTR)
19/09/201711/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom
4EUCTR2017-000571-85-LT
(EUCTR)
15/09/201720/07/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
5EUCTR2017-000571-85-HU
(EUCTR)
15/06/201713/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-000571-85-ES
(EUCTR)
01/06/201721/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
7EUCTR2015-002739-17-CZ
(EUCTR)
09/03/201613/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Hungary;Czech Republic;Canada;Spain;Israel
8EUCTR2015-002739-17-HU
(EUCTR)
30/12/201513/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
9EUCTR2015-002739-17-ES
(EUCTR)
16/12/201503/11/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
10EUCTR2014-004519-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2014-004519-35-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
12EUCTR2014-004519-35-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
13EUCTR2014-004519-35-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
14NCT02372383
(ClinicalTrials.gov)
October 201420/6/2014Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic FibrosisPharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus ControlsCystic FibrosisDrug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: PancrelipaseUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences InstituteCompleted16 Years45 YearsBoth32N/AUnited States
15EUCTR2013-002819-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-002819-10-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
17EUCTR2009-012842-21-HU
(EUCTR)
27/06/201310/05/2013Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
18EUCTR2009-012842-21-BE
(EUCTR)
19/11/201214/05/2012Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
19NCT01747330
(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
20EUCTR2009-012842-21-BG
(EUCTR)
24/02/201128/09/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-012842-21-DE
(EUCTR)
13/01/201113/07/2010Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
22NCT00775528
(ClinicalTrials.gov)
April 200917/10/2008Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisAn 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 FibrosisCystic Fibrosis;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase Delayed ReleaseSolvay PharmaceuticalsNULLCompleted1 Month6 YearsAll19Phase 3United States
23NCT00744250
(ClinicalTrials.gov)
August 200828/8/2008Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo ControlIntraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic FibrosisDrug: PancrelipaseDigestive Care, Inc.University of North Carolina, Chapel HillTerminated18 YearsN/ABoth3Phase 4United States
24NCT00662675
(ClinicalTrials.gov)
August 200817/4/2008A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic InsufficiencyA 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 InsufficiencyExocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic FibrosisDrug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21Johnson & Johnson Pharmaceutical Research & Development, L.L.C.NULLCompleted7 Years60 YearsAll40Phase 3United States;Canada
25NCT00690820
(ClinicalTrials.gov)
June 20083/6/2008Study 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 FibrosisCystic Fibrosis;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase Delayed Release;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted7 Years11 YearsAll17Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2007-004004-12-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
27NCT00510484
(ClinicalTrials.gov)
November 20071/8/2007Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA 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 FibrosisCystic FibrosisDrug: Pancrelipase Delayed Release;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted12 YearsN/AAll35Phase 3United States;Hungary;Israel;South Africa;Spain
28NCT00432861
(ClinicalTrials.gov)
January 20077/2/2007Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic FibrosisA 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 FibrosisCystic Fibrosis;Pancreatic InsufficiencyDrug: PANCRECARB® (pancrelipase);Drug: PlaceboDigestive Care, Inc.NULLCompleted7 YearsN/ABoth29Phase 3United States
29NCT00217204
(ClinicalTrials.gov)
July 200513/9/2005An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat MalabsorptionA 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 MalabsorptionCystic Fibrosis;SteatorrheaDrug: Pancrelipase microtabletsMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.NULLCompleted6 Months30 MonthsBoth18Phase 2Belgium;Netherlands
30NCT00006063
(ClinicalTrials.gov)
July 19995/7/2000Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic FibrosisCystic FibrosisDrug: pancrelipase with bicarbonateNational Center for Research Resources (NCRR)Indiana University School of MedicineCompletedN/AN/ABoth24N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
31EUCTR2005-001438-34-BE
(EUCTR)
15/07/2005A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionA Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionTrade Name: Panzytrat® ok
Product Name: Pancrelipase Microtablets
Product Code: N/A
INN or Proposed INN: Pancreatin
McNeil Consumer and Specialty PharmaceuticalsNULLNAFemale: yes
Male: yes
20Phase 2Belgium
32EUCTR2015-001219-11-Outside-EU/EEA
(EUCTR)
31/03/2015A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiencyA 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.NULLNAFemale: yes
Male: yes
40Phase 3United States;Canada
33EUCTR2010-019267-11-DE
(EUCTR)
19/10/2010AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: LLT;Classification code 10041968;Term: Steatorrhea;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: PANZYTRAT 25000
Product Name: PANZYTRAT 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: KREON 25000
Product Name: KREON 25000
Other descriptive name: PANCREATIN
Axcan Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
68Germany
34EUCTR2017-000571-85-PL
(EUCTR)
08/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom