Omnitrop ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
78Hypopituitarism8

78. Hypopituitarism


Clinical trials : 494 Drugs : 385 - (DrugBank : 49) / Drug target genes : 44 - Drug target pathways : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01247675
(ClinicalTrials.gov)
November 201023/11/2010A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone DeficiencyA Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyDrug: ACP-001 (TransCon hGH);Drug: OmnitropeAscendis Pharma A/SNULLCompleted20 Years70 YearsAll37Phase 2Denmark;Germany;Italy;Sweden
2EUCTR2010-021523-28-DE
(EUCTR)
05/10/201010/08/2010A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrop
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
3EUCTR2010-021523-28-IT
(EUCTR)
28/09/201027/12/2010A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - NDA phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND 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 Proposed INN: Somatropin
ASCENDIS PHARMA A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Germany;Denmark;Italy;Austria;Sweden
4EUCTR2010-021523-28-SE
(EUCTR)
27/09/201006/08/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: Omnitrop
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
5EUCTR2010-021523-28-DK
(EUCTR)
13/09/201029/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrop
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Austria;Denmark;Germany;Italy;Sweden
6EUCTR2010-019374-32-SI
(EUCTR)
13/09/201004/06/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Omnitrop
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: ecombinanat DNA-derived human growth h
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
7EUCTR2010-021523-28-AT
(EUCTR)
02/09/201020/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrop
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
8NCT01298180
(ClinicalTrials.gov)
January 20096/11/2009Is 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 DeficiencyDrug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsyUniversity Hospital, ToulouseNULLCompleted1 Year5 YearsAll111Phase 4France