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
| 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 | NCT04970654 (ClinicalTrials.gov) | July 22, 2021 | 12/7/2021 | A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. | A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency | Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: Norditropin® | Novo Nordisk A/S | NULL | Recruiting | N/A | N/A | All | 108 | Phase 3 | China |
| 2 | NCT04614337 (ClinicalTrials.gov) | December 31, 2020 | 26/10/2020 | Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) | A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Idiopathic Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency | Drug: LUM-201;Drug: rhGH Norditropin® pen (34 µg/kg) | Lumos Pharma | NULL | Active, not recruiting | 3 Years | 12 Years | All | 80 | Phase 2 | United States;Australia;Israel;New Zealand;Poland;Ukraine;Russian Federation |
| 3 | EUCTR2018-000231-27-ES (EUCTR) | 21/04/2020 | 28/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 4 | EUCTR2018-000231-27-PL (EUCTR) | 23/03/2020 | 04/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Germany;Norway;Japan;United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland | ||
| 5 | EUCTR2018-000231-27-HU (EUCTR) | 23/03/2020 | 05/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | ||
| 6 | EUCTR2018-000231-27-LV (EUCTR) | 05/03/2020 | 15/01/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Germany;Latvia;Norway;Algeria;Japan;Korea, Republic of | ||
| 7 | EUCTR2018-000231-27-EE (EUCTR) | 17/02/2020 | 14/01/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 8 | EUCTR2018-000231-27-SI (EUCTR) | 17/07/2019 | 14/06/2019 | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Japan | ||
| 9 | NCT03972345 (ClinicalTrials.gov) | June 21, 2019 | 31/5/2019 | Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | Growth Hormone Deficiency in Children;Born Small for Gestational Age | Drug: Norditropin® FlexPro® | Novo Nordisk A/S | NULL | Enrolling by invitation | 0 Years | 15 Years | All | 750 | Germany | |
| 10 | EUCTR2018-000231-27-GB (EUCTR) | 30/05/2019 | 03/09/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Russian Federation;United States;Thailand;Austria;Latvia;Ireland;Korea, Republic of;Poland;Algeria;Slovenia;France;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;Canada;European Union;Norway;Denmark;Italy;Israel;Germany;Estonia | ||
| 11 | EUCTR2018-000231-27-AT (EUCTR) | 22/05/2019 | 02/04/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 12 | NCT03811535 (ClinicalTrials.gov) | May 20, 2019 | 18/1/2019 | A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day | A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency | Growth Hormone Deficiency in Children | Drug: Somapacitan;Drug: Norditropin® | Novo Nordisk A/S | NULL | Active, not recruiting | N/A | 11 Years | All | 200 | Phase 3 | United States;Algeria;Austria;Canada;Estonia;France;Germany;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Norway;Poland;Russian Federation;Serbia;Slovenia;Spain;Switzerland;Thailand;Ukraine;United Kingdom;Denmark;Hungary |
| 13 | EUCTR2018-000231-27-DK (EUCTR) | 15/05/2019 | 28/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Algeria;Japan | ||
| 14 | EUCTR2018-000231-27-DE (EUCTR) | 23/04/2019 | 11/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 15 | EUCTR2018-000231-27-IT (EUCTR) | 19/04/2019 | 30/07/2021 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 Product Code: [NN8640] INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290S Product Code: [NN8640] INN or Proposed INN: Somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 Product Code: [NN8640] INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml Product Name: Norditropin FlexPro 10 mg/1.5 ml Product Code: [N/A] INN or Proposed INN: somatropin Other descriptive name: somatropin | NOVO NORDISK. S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;Canada;Poland;Germany;Norway;Algeria;Japan | ||
| 16 | NCT04513171 (ClinicalTrials.gov) | December 26, 2018 | 7/8/2020 | Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children | A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency. | Growth Hormone Deficiency | Drug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: Norditropin | Xiamen Amoytop Biotech Co., Ltd. | Tongji Hospital | Active, not recruiting | 3 Years | 11 Years | All | 434 | Phase 2/Phase 3 | China |
| 17 | NCT03075644 (ClinicalTrials.gov) | March 3, 2017 | 28/2/2017 | A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 62 | Phase 3 | Japan |
| 18 | NCT02616562 (ClinicalTrials.gov) | March 23, 2016 | 25/11/2015 | Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: Norditropin® FlexPro® pen | Novo Nordisk A/S | NULL | Recruiting | 30 Months | 10 Years | All | 74 | Phase 2 | United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine |
| 19 | EUCTR2015-000531-32-DE (EUCTR) | 14/03/2016 | 20/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 20 | EUCTR2015-000531-32-BE (EUCTR) | 17/02/2016 | 30/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden | ||
| 21 | EUCTR2015-000531-32-SE (EUCTR) | 14/01/2016 | 04/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 22 | EUCTR2015-000531-32-SI (EUCTR) | 15/12/2015 | 11/11/2015 | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 23 | EUCTR2015-000531-32-AT (EUCTR) | 10/12/2015 | 03/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 24 | EUCTR2013-002892-16-LV (EUCTR) | 12/10/2015 | 31/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden | ||
| 25 | EUCTR2013-002892-16-LT (EUCTR) | 30/09/2015 | 27/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 26 | NCT02382939 (ClinicalTrials.gov) | February 12, 2015 | 10/2/2015 | A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency;Growth Hormone Disorder | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 92 | Phase 3 | Denmark;France;Germany;Japan;Sweden;United Kingdom |
| 27 | EUCTR2014-000290-39-GB (EUCTR) | 30/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | European Union;Denmark;Japan;United Kingdom;Sweden | ||
| 28 | EUCTR2014-000290-39-DK (EUCTR) | 22/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | |||
| 29 | EUCTR2013-002892-16-DE (EUCTR) | 22/12/2014 | 29/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 30 | EUCTR2013-002892-16-GB (EUCTR) | 20/11/2014 | 24/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 31 | EUCTR2014-000290-39-SE (EUCTR) | 07/11/2014 | 07/10/2014 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | |||
| 32 | NCT02229851 (ClinicalTrials.gov) | October 31, 2014 | 26/8/2014 | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 23 Years | 79 Years | All | 301 | Phase 3 | United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom |
| 33 | EUCTR2013-002892-16-SE (EUCTR) | 07/10/2014 | 03/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 34 | EUCTR2013-000013-20-ES (EUCTR) | 02/01/2014 | 10/01/2014 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 1 | France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Belgium;Spain;Austria;Israel;Norway;Switzerland;Sweden | ||
| 35 | EUCTR2013-000013-20-SE (EUCTR) | 20/12/2013 | 12/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 36 | EUCTR2013-000013-20-BE (EUCTR) | 17/12/2013 | 11/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 37 | NCT01973244 (ClinicalTrials.gov) | December 16, 2013 | 22/10/2013 | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 13 Years | All | 32 | Phase 1 | Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland |
| 38 | EUCTR2013-000013-20-AT (EUCTR) | 16/12/2013 | 11/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 39 | EUCTR2013-000013-20-SI (EUCTR) | 09/12/2013 | 20/09/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 40 | EUCTR2010-018586-39-DK (EUCTR) | 01/06/2010 | 12/05/2010 | Diurnal variation of exogenous peptides - Gh Puls/Jurgita I | Diurnal variation of exogenous peptides - Gh Puls/Jurgita I | Adults with growth hormone disease (AGHD). | Trade Name: Norditropin® SimpleXx® 5 mg/1.5ml Other descriptive name: GROWTH HORMONE | Medical Department M (Endocrinology & Diabetes) | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 2 | Denmark | ||
| 41 | NCT01109017 (ClinicalTrials.gov) | October 2009 | 19/4/2010 | Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency | A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 387 | N/A | Japan |
| 42 | NCT00934063 (ClinicalTrials.gov) | July 2009 | 2/7/2009 | An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® | A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin) | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Other: No treatment given | Novo Nordisk A/S | NULL | Completed | 18 Years | N/A | Both | 121 | N/A | Germany |
| 43 | NCT00960128 (ClinicalTrials.gov) | April 1, 2006 | 13/8/2009 | Observational Prospective Study on Patients Treated With Norditropin® | NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin® | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 21249 | N/A | Argentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro |
| 44 | NCT01604161 (ClinicalTrials.gov) | May 2005 | 21/5/2012 | Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome | A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs. | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 2016 | N/A | Japan |
| 45 | NCT00567385 (ClinicalTrials.gov) | March 10, 2003 | 30/11/2007 | Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 18 Years | All | 176 | Phase 4 | Turkey |
| 46 | NCT01009905 (ClinicalTrials.gov) | June 24, 2002 | 5/11/2009 | An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) | Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone | Growth Hormone Disorder;Pituitary Dwarfism;Hypopituitarism | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 18 Years | All | 22960 | N/A | United States |
| 47 | NCT00184678 (ClinicalTrials.gov) | February 2002 | 13/9/2005 | Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency | Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 25 Years | All | 161 | Phase 3 | Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom |
| 48 | NCT01502124 (ClinicalTrials.gov) | May 8, 2001 | 29/12/2011 | Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency | Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 17 Years | All | 78 | Phase 3 | United States |
| 49 | NCT00931476 (ClinicalTrials.gov) | April 6, 2000 | 30/6/2009 | A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin | A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24) | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Healthy | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 20 Years | 50 Years | Male | 86 | Phase 1 | United States |
| 50 | NCT01562834 (ClinicalTrials.gov) | October 21, 1998 | 22/3/2012 | Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients | Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 50 Years | All | 22 | Phase 4 | France |
| 51 | EUCTR2018-000231-27-IE (EUCTR) | 26/11/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 52 | EUCTR2018-000231-27-FR (EUCTR) | 25/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Norway;Germany;Algeria;Japan;Korea, Republic of | |||
| 53 | EUCTR2013-000013-20-FR (EUCTR) | 25/09/2015 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 32 | Phase 1 | France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 54 | EUCTR2018-000231-27-NO (EUCTR) | 14/11/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Phase 3 | Russian Federation;United States;Thailand;Austria;Latvia;Ireland;Korea, Republic of;Poland;Algeria;Slovenia;Serbia;France;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;Canada;Norway;European Union;Denmark;Italy;Israel;Germany;Estonia |