PANCREASE MT ( 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2

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
1NCT00662675
(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
2EUCTR2015-001219-11-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