Nutropinaq (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 78 | 下垂体前葉機能低下症 | 13 |
| 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 | EUCTR2011-005377-23-ES (EUCTR) | 18/07/2012 | 21/05/2012 | Study 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 Cambra | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain | ||
| 2 | EUCTR2010-020742-10-GB (EUCTR) | 09/05/2011 | 04/11/2010 | 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. | 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 3 | EUCTR2010-020742-10-ES (EUCTR) | 01/04/2011 | 07/01/2011 | Tratamiento 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 | Tratamiento 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Finland;United Kingdom;Spain;Sweden | |||
| 4 | EUCTR2010-020742-10-SE (EUCTR) | 23/02/2011 | 19/11/2010 | Comparison 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 5 | EUCTR2010-020742-10-FI (EUCTR) | 10/01/2011 | 22/11/2010 | Comparison 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 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 |
| 6 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 7 | EUCTR2010-019374-32-SI (EUCTR) | 13/09/2010 | 04/06/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 8 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 9 | EUCTR2010-019735-35-FR (EUCTR) | 14/06/2010 | 30/04/2010 | Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien | Effets 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 Amiens | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 10 | EUCTR2004-000356-17-FI (EUCTR) | 16/05/2006 | 14/03/2006 | PHASE 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 | PHASE 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 Scandinavia | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3B | Finland;Denmark;Italy | ||
| 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 |
| 11 | EUCTR2004-000356-17-DK (EUCTR) | 19/04/2005 | 29/11/2004 | PHASE 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 | PHASE 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3B | Finland;Denmark;Italy | ||
| 12 | EUCTR2004-000356-17-AT (EUCTR) | 12/03/2005 | 02/05/2005 | Phase 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 | Phase 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3B | Finland;Denmark;Austria;Italy | ||
| 13 | EUCTR2004-000356-17-SE (EUCTR) | 11/07/2005 | PHASE 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 | PHASE 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 Scandinavia | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Finland;Spain;Austria;Denmark;Italy;Sweden |