EUR-1008 (APT-1008) ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症4

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_
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agemin
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PhaseCountries
1NCT01131507
(ClinicalTrials.gov)
July 201025/5/2010PR-018: An Open-Label, Safety Extension of Study PR-011A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompletedN/A12 MonthsAll15Phase 4United States
2NCT01100606
(ClinicalTrials.gov)
June 201031/3/2010A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of AgeA Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompleted1 Month12 MonthsAll15Phase 4United States
3NCT00297167
(ClinicalTrials.gov)
May 200627/2/2006Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyA Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008);Drug: PlaceboForest LaboratoriesNULLCompleted7 YearsN/AAll34Phase 3United States
4NCT00981214
(ClinicalTrials.gov)
May 200621/9/2009Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyAn Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompletedN/A7 YearsAll19Phase 3United States