Norditropin NordiFlex® ( 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 | 9 |
78. 下垂体前葉機能低下症
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
| 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 | NCT01706783 (ClinicalTrials.gov) | October 12, 2012 | 11/10/2012 | A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin NordiFlex® | Novo Nordisk A/S | NULL | Completed | 20 Years | 70 Years | All | 35 | Phase 1 | Denmark;Sweden |
| 2 | NCT01327924 (ClinicalTrials.gov) | April 2011 | 31/3/2011 | Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone | Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Delivery Systems | Drug: Norditropin NordiFlex® | Novo Nordisk A/S | NULL | Completed | N/A | 16 Years | Both | 77 | N/A | France |
| 3 | EUCTR2008-008240-25-ES (EUCTR) | 04/11/2009 | 10/08/2009 | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Déficit de hormona de crecimientogrowth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Slovenia;Belgium;Spain;Denmark;United Kingdom | ||
| 4 | EUCTR2008-008240-25-DK (EUCTR) | 12/10/2009 | 17/08/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Slovenia;Denmark;France;Spain | |||
| 5 | EUCTR2008-008240-25-GB (EUCTR) | 01/10/2009 | 18/06/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 6 | EUCTR2008-008240-25-FR (EUCTR) | 02/09/2009 | 10/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | ||
| 7 | NCT00936403 (ClinicalTrials.gov) | August 2009 | 9/7/2009 | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone | A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: NNC126-0083;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 12 Years | All | 31 | Phase 2 | Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom |
| 8 | EUCTR2008-008240-25-BE (EUCTR) | 10/06/2009 | 24/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | |||
| 9 | EUCTR2008-008240-25-SI (EUCTR) | 25/05/2009 | 06/05/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain |