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	NCT00558844 (ClinicalTrials.gov)	January 2008	13/11/2007	Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa	Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa.	Cystic Fibrosis	Drug: Arikayce™ 560 mg;Drug: Placebo for 560 mg;Drug: Arikayce™ 70 mg;Drug: Arikayce™ 140 mg;Drug: Placebo for 70 mg / 140 mg	Insmed Incorporated	NULL	Completed	6 Years	N/A	All	41	Phase 1;Phase 2	United States

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

NCT00558844
(ClinicalTrials.gov)

January 2008

13/11/2007

Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa.

Cystic Fibrosis

Drug: Arikayce™ 560 mg;Drug: Placebo for 560 mg;Drug: Arikayce™ 70 mg;Drug: Arikayce™ 140 mg;Drug: Placebo for 70 mg / 140 mg

Insmed Incorporated

NULL

Completed

6 Years

N/A

All

Phase 1;Phase 2

United States