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	3

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	NCT01100892 (ClinicalTrials.gov)	December 2010	31/3/2010	Cystic Fibrosis - Insulin Deficiency, Early Action	Cystic Fibrosis - Insulin Deficiency, Early Action	Cystic Fibrosis;Diabetes	Drug: Once-daily insulin detemir	Sydney Children's Hospitals Network	John Hunter Children's Hospital;Lady Cilento Children's Hospital, Brisbane;Women's and Children's Hospital, Adelaide	Recruiting	5 Years	19 Years	All	100	Phase 3	Australia
2	NCT00639626 (ClinicalTrials.gov)	August 2008	14/3/2008	Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)	Use of Levemir® Improves Metabolic and Clinical Status in CFRD	Cystic Fibrosis Related Diabetes	Drug: insulin detemir [rDNA origin] injection	Nationwide Children's Hospital	Novo Nordisk A/S	Terminated	16 Years	45 Years	All	6	Phase 2;Phase 3	United States
3	EUCTR2005-002997-31-GB (EUCTR)	10/08/2006	09/11/2005	A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes	A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes	Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.		Sheffield Children's NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	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

NCT01100892
(ClinicalTrials.gov)

December 2010

31/3/2010

Cystic Fibrosis - Insulin Deficiency, Early Action

Cystic Fibrosis;Diabetes

Drug: Once-daily insulin detemir

Sydney Children's Hospitals Network

John Hunter Children's Hospital;Lady Cilento Children's Hospital, Brisbane;Women's and Children's Hospital, Adelaide

Recruiting

5 Years

19 Years

All

100

Phase 3

Australia

NCT00639626
(ClinicalTrials.gov)

August 2008

14/3/2008

Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)

Use of Levemir® Improves Metabolic and Clinical Status in CFRD

Cystic Fibrosis Related Diabetes

Drug: insulin detemir [rDNA origin] injection

Nationwide Children's Hospital

Novo Nordisk A/S

Terminated

16 Years

45 Years

All

Phase 2;Phase 3

United States

EUCTR2005-002997-31-GB
(EUCTR)

10/08/2006

09/11/2005

A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes

Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.

Sheffield Children's NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom