Nutropinaq 10 mg/2 ml (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 | 5 |
| 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 |