OMNITROPE

( DrugBank: - / KEGG DRUG: - )

2 diseases

ID	Disease name (Link within this page)	Number of trials
78	Hypopituitarism	7

ID	Disease name (Link within this page)	Number of trials
193	Prader-Willi syndrome	2

78. Hypopituitarism

Clinical trials : 492 / Drugs : 341 - (DrugBank : 47) / Drug target genes : 45 - Drug target pathways : 100

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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	NCT01247675 (ClinicalTrials.gov)	November 2010	23/11/2010	A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth ...	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	Adult Growth Hormone Deficiency	Drug: ACP-001 (TransCon hGH);Drug: Omnitrope	Ascendis Pharma A/S	NULL	Completed	20 Years	70 Years	All	37	Phase 2	Denmark;Germany;Italy;Sweden
2	EUCTR2010-021523-28-DE (EUCTR)	05/10/2010	10/08/2010	A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone ...	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth h ...	Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN o ...	Ascendis Pharma A/S	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Denmark;Austria;Germany;Italy;Sweden
3	EUCTR2010-021523-28-IT (EUCTR)	28/09/2010	27/12/2010	A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharm ...	A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharm ...	Growth Hormone Deficiency MedDRA version: 9.1;Level: PT;Classification code 10056438	Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: OMNITROPE INN or ...	ASCENDIS PHARMA A/S	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Germany;Denmark;Italy;Austria;Sweden
4	EUCTR2010-021523-28-SE (EUCTR)	27/09/2010	06/08/2010	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth h ...	Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: Omnitrope® INN o ...	Ascendis Pharma A/S	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Denmark;Austria;Germany;Italy;Sweden
5	EUCTR2010-021523-28-DK (EUCTR)	13/09/2010	29/07/2010	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth h ...	Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN o ...	Ascendis Pharma A/S	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Austria;Denmark;Germany;Italy;Sweden
6	EUCTR2010-021523-28-AT (EUCTR)	02/09/2010	20/07/2010	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharm ...	Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth h ...	Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN o ...	Ascendis Pharma A/S	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Denmark;Austria;Germany;Italy;Sweden
7	NCT01298180 (ClinicalTrials.gov)	January 2009	6/11/2009	Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?	Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?	Prader-Willi Syndrome;Growth Hormone Deficiency	Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age. ...	University Hospital, Toulouse	NULL	Completed	1 Year	5 Years	All	111	Phase 4	France

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193. Prader-Willi syndrome

Clinical trials : 113 / Drugs : 111 - (DrugBank : 26) / Drug target genes : 48 - Drug target pathways : 102

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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	NCT01298180 (ClinicalTrials.gov)	January 2009	6/11/2009	Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?	Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?	Prader-Willi Syndrome;Growth Hormone Deficiency	Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age. ...	University Hospital, Toulouse	NULL	Completed	1 Year	5 Years	All	111	Phase 4	France
2	EUCTR2008-004612-12-FR (EUCTR)	06/11/2008	14/11/2008	Existe t-il une sensibilité accrue à l’hormone de croissance chez les enfants présentant un syndrome ...	Existe t-il une sensibilité accrue à l’hormone de croissance chez les enfants présentant un syndrome ...	- syndrome de Prader-Willi- déficit en hormone de croissance MedDRA version: 9.1;Level: LLT;Classifi ...	Trade Name: genotonorm Product Name: GENOTONORM Trade Name: omnitrope Product Name: OMNITROPE	CHU TOULOUSE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France

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