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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1NCT01706783
(ClinicalTrials.gov)
October 12, 201211/10/2012A 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: Norditropin NordiFlex®Novo Nordisk A/SNULLCompleted20 Years70 YearsAll35Phase 1Denmark;Sweden
2NCT01327924
(ClinicalTrials.gov)
April 201131/3/2011Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth HormoneEase of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily LifeGrowth 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 SystemsDrug: Norditropin NordiFlex®Novo Nordisk A/SNULLCompletedN/A16 YearsBoth77N/AFrance
3EUCTR2008-008240-25-ES
(EUCTR)
04/11/200910/08/2009Ensayo 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 childrenEnsayo 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/SNULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Slovenia;Belgium;Spain;Denmark;United Kingdom
4EUCTR2008-008240-25-DK
(EUCTR)
12/10/200917/08/2009A 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 childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Slovenia;Denmark;France;Spain
5EUCTR2008-008240-25-GB
(EUCTR)
01/10/200918/06/2009A 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 childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Denmark;Slovenia;France;Spain
6EUCTR2008-008240-25-FR
(EUCTR)
02/09/200910/04/2009A 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 childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
6Phase 2France;Slovenia;Spain;Belgium;Denmark;United Kingdom
7NCT00936403
(ClinicalTrials.gov)
August 20099/7/2009A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth HormoneA 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 ChildrenGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: NNC126-0083;Drug: somatropinNovo Nordisk A/SNULLCompleted6 Years12 YearsAll31Phase 2Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom
8EUCTR2008-008240-25-BE
(EUCTR)
10/06/200924/04/2009A 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 childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
32France;Slovenia;Spain;Belgium;Denmark;United Kingdom
9EUCTR2008-008240-25-SI
(EUCTR)
25/05/200906/05/2009A 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 childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Denmark;Slovenia;France;Spain