DDrare: Database of Drug Development for Rare Diseases

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	1

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	NCT01641393 (ClinicalTrials.gov)	June 2012	10/7/2012	Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.	A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis	Exocrine Pancreatic Insufficiency: Cystic Fibrosis	Drug: EUR-1008 25,000 Units;Drug: Kreon 25,000 Units	Aptalis Pharma	NULL	Completed	12 Years	N/A	Both	96	Phase 3	Belgium;Bulgaria;France;Germany;Italy;Poland;United Kingdom

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

NCT01641393
(ClinicalTrials.gov)

June 2012

10/7/2012

Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

Exocrine Pancreatic Insufficiency: Cystic Fibrosis

Drug: EUR-1008 25,000 Units;Drug: Kreon 25,000 Units

Aptalis Pharma

NULL

Completed

12 Years

N/A

Both

Phase 3

Belgium;Bulgaria;France;Germany;Italy;Poland;United Kingdom