78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100

  
13 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
1EUCTR2011-005377-23-ES
(EUCTR)
18/07/201221/05/2012Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD). Spinal Cord Injury and Growth Hormone Deficiency
MedDRA version: 14.1;Level: PT;Classification code 10041558;Term: Spinal cord injury thoracic;System Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 14.1;Classification code 10041554;Term: Spinal cord injury cervical;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Trade Name: NUTROPIN
Product Name: NutropinAq 10 mg/2 ml (30 UI)
INN or Proposed INN: SOMATROPIN
Guillem Cuatrecasas CambraNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain
2EUCTR2010-020742-10-GB
(EUCTR)
09/05/201104/11/2010Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
3EUCTR2010-020742-10-ES
(EUCTR)
01/04/201107/01/2011Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplicaTratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica Niños pre-puberales con déficit idiopático de hormona de crecimiento
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable
INN or Proposed INN: SOMATROPINA
Other descriptive name: SOMATROPIN
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Finland;United Kingdom;Spain;Sweden
4EUCTR2010-020742-10-SE
(EUCTR)
23/02/201119/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
5EUCTR2010-020742-10-FI
(EUCTR)
10/01/201122/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;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
7EUCTR2010-019374-32-HU
(EUCTR)
13/09/201018/05/2010A 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: Saizen
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
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
8EUCTR2010-019374-32-SK
(EUCTR)
15/07/201014/05/2010A 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: Saizen
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
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
9EUCTR2010-019735-35-FR
(EUCTR)
14/06/201030/04/2010Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânienEffets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien Déficit somatotrope de l'adulte consécutif à un traumatisme crânien
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Nutropin Aq
Product Name: NutropinAq
CHU AmiensNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
10EUCTR2004-000356-17-FI
(EUCTR)
16/05/200614/03/2006PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
Ipsen ScandinaviaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Italy
11EUCTR2004-000356-17-DK
(EUCTR)
19/04/200529/11/2004PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Italy
12EUCTR2004-000356-17-AT
(EUCTR)
12/03/200502/05/2005Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - OptimaPhase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq(tm) is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Austria;Italy
13EUCTR2004-000356-17-SE
(EUCTR)
11/07/2005PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
Ipsen ScandinaviaNULLNot RecruitingFemale: yes
Male: yes
250Phase 4Finland;Spain;Austria;Denmark;Italy;Sweden