Norditropin FlexPro 10 mg/1.5 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 | 18 |
78. 下垂体前葉機能低下症
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | 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;Latvia;Norway;Germany;Algeria;Japan;Korea, Republic of | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 17 | 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 | |||
| 18 | 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 |