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	2

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	EUCTR2014-004519-35-ES (EUCTR)	30/01/2015	04/12/2014	A 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	A 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 GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	78	Phase 2	Czech Republic;Hungary;Spain;United Kingdom
2	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

EUCTR2014-004519-35-ES
(EUCTR)

30/01/2015

04/12/2014

A 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 GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Spain;United Kingdom

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