Norditropin flexpro 10 mg (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 | 15 |
| 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-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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | |||
| 10 | 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 | ||
| 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 |
| 11 | 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 | |||
| 12 | 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 | ||
| 13 | EUCTR2018-000231-27-DE (EUCTR) | 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 | NA | 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-PL (EUCTR) | 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 | NA | 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 | |||
| 15 | 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 |