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	NCT01327703 (ClinicalTrials.gov)	April 2011	28/3/2011	Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency	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)	Exocrine Pancreatic Insufficiency;Cystic Fibrosis	Drug: Panzytrat® 25,000;Drug: Kreon® 25,000	Forest Laboratories	NULL	Completed	7 Years	N/A	All	87	Phase 4	Germany;Poland

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

NCT01327703
(ClinicalTrials.gov)

April 2011

28/3/2011

Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

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)

Exocrine Pancreatic Insufficiency;Cystic Fibrosis

Drug: Panzytrat® 25,000;Drug: Kreon® 25,000

Forest Laboratories

NULL

Completed

7 Years

N/A

All

Phase 4

Germany;Poland