Somapacitan (DrugBank: Somapacitan)
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 | 24 |
| 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 | 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] | 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;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 5 | EUCTR2018-000231-27-SI (EUCTR) | 17/07/2019 | 14/06/2019 | 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] | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Slovenia;Thailand;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Algeria;Japan;Korea, Republic of | |||
| 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 | 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] | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | 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 | |||
| 7 | 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] | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | 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 | |||
| 8 | 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 | 2 Years | 11 Years | All | 192 | Phase 3 | United States;Algeria;Austria;Canada;Denmark;Estonia;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Norway;Poland;Russian Federation;Serbia;Slovenia;Spain;Switzerland;Thailand;Ukraine;United Kingdom |
| 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] | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Slovenia;Thailand;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Algeria;Japan;Korea, Republic of | |||
| 10 | NCT03905850 (ClinicalTrials.gov) | March 29, 2019 | 3/4/2019 | A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects | A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL | Healthy Volunteers;Growth Hormone Deficiency | Drug: somapacitan | Novo Nordisk A/S | NULL | Completed | 18 Years | 45 Years | All | 33 | Phase 1 | Germany |
| 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 | NCT03212131 (ClinicalTrials.gov) | August 16, 2017 | 30/6/2017 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function. | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children | Drug: Somapacitan | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 34 | Phase 1 | Slovakia |
| 12 | NCT03186495 (ClinicalTrials.gov) | June 20, 2017 | 12/6/2017 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children | Drug: Somapacitan | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 44 | Phase 1 | Germany |
| 13 | 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 |
| 14 | 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 Trial 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 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 | N/A | 17 Years | All | 74 | Phase 2 | United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine |
| 15 | 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 |
| 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | NCT01706783 (ClinicalTrials.gov) | October 12, 2012 | 11/10/2012 | A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin NordiFlex® | Novo Nordisk A/S | NULL | Completed | 20 Years | 70 Years | All | 35 | Phase 1 | Denmark;Sweden |
| 19 | NCT01514500 (ClinicalTrials.gov) | January 16, 2012 | 13/1/2012 | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children;Healthy | Drug: somapacitan;Drug: placebo (somapacitan) | Novo Nordisk A/S | NULL | Completed | 20 Years | 45 Years | Male | 105 | Phase 1 | Germany |
| 20 | 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] | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Phase 3 | 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 | ||||
| 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 |
| 21 | 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] | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Phase 3 | 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 | ||||
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 |