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

  
28 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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agemax
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PhaseCountries
1NCT05718570
(ClinicalTrials.gov)
February 3, 202330/1/2023A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety InformationA Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical PracticeAdult Growth Hormone DeficiencyDrug: SomapacitanNovo Nordisk A/SNULLRecruiting18 YearsN/AAll400Slovenia
2NCT05230550
(ClinicalTrials.gov)
February 3, 202228/1/2022Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in JapanAdult Growth Hormone DeficiencyDrug: SomapacitanNovo Nordisk A/SNULLEnrolling by invitationN/AN/AAll200Japan
3NCT04970654
(ClinicalTrials.gov)
July 22, 202112/7/2021A 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 DeficiencyGrowth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: Norditropin®Novo Nordisk A/SNULLRecruitingN/AN/AAll108Phase 3China
4EUCTR2018-000231-27-ES
(EUCTR)
21/04/202028/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;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
5EUCTR2018-000231-27-HU
(EUCTR)
23/03/202005/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;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
6EUCTR2018-000231-27-PL
(EUCTR)
23/03/202004/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Germany;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
7EUCTR2018-000231-27-LV
(EUCTR)
05/03/202015/01/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;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
8EUCTR2018-000231-27-EE
(EUCTR)
17/02/202014/01/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLNot RecruitingFemale: yes
Male: yes
192Phase 3Serbia;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
9EUCTR2018-000231-27-SI
(EUCTR)
17/07/201914/06/2019A 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
10EUCTR2018-000231-27-GB
(EUCTR)
30/05/201903/09/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Russian 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
11EUCTR2018-000231-27-AT
(EUCTR)
22/05/201902/04/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
12NCT03811535
(ClinicalTrials.gov)
May 20, 201918/1/2019A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a DayA Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone DeficiencyGrowth Hormone Deficiency in ChildrenDrug: Somapacitan;Drug: Norditropin®Novo Nordisk A/SNULLActive, not recruitingN/A11 YearsAll200Phase 3United 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
13EUCTR2018-000231-27-DK
(EUCTR)
15/05/201928/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLNot RecruitingFemale: yes
Male: yes
192Phase 3United 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
14EUCTR2018-000231-27-DE
(EUCTR)
23/04/201911/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
15EUCTR2018-000231-27-IT
(EUCTR)
19/04/201930/07/2021A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
16NCT03905850
(ClinicalTrials.gov)
March 29, 20193/4/2019A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy SubjectsA 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 mLHealthy Volunteers;Growth Hormone DeficiencyDrug: somapacitanNovo Nordisk A/SNULLCompleted18 Years45 YearsAll33Phase 1Germany
17NCT03212131
(ClinicalTrials.gov)
August 16, 201730/6/2017Investigation 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 FunctionGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in ChildrenDrug: SomapacitanNovo Nordisk A/SNULLCompleted18 Years75 YearsAll34Phase 1Slovakia
18NCT03186495
(ClinicalTrials.gov)
June 20, 201712/6/2017Investigation 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 FunctionInvestigation 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 FunctionGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in ChildrenDrug: SomapacitanNovo Nordisk A/SNULLCompleted18 Years75 YearsAll44Phase 1Germany
19NCT03075644
(ClinicalTrials.gov)
March 3, 201728/2/2017A 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: NorditropinNovo Nordisk A/SNULLCompleted18 Years79 YearsAll62Phase 3Japan
20NCT02616562
(ClinicalTrials.gov)
March 23, 201625/11/2015Investigating 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: Norditropin® FlexPro® penNovo Nordisk A/SNULLRecruiting30 Months10 YearsAll74Phase 2United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine
21NCT02382939
(ClinicalTrials.gov)
February 12, 201510/2/2015A 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 DeficiencyA 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 DeficiencyAdult Growth Hormone Deficiency;Growth Hormone DisorderDrug: somapacitan;Drug: somatropinNovo Nordisk A/SNULLCompleted18 Years79 YearsAll92Phase 3Denmark;France;Germany;Japan;Sweden;United Kingdom
22NCT02229851
(ClinicalTrials.gov)
October 31, 201426/8/2014Trial 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 PeriodGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted23 Years79 YearsAll301Phase 3United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom
23NCT01973244
(ClinicalTrials.gov)
December 16, 201322/10/2013A 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: somatropinNovo Nordisk A/SNULLCompleted6 Years13 YearsAll32Phase 1Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland
24NCT01706783
(ClinicalTrials.gov)
October 12, 201211/10/2012A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone DeficiencyA Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: Norditropin NordiFlex®Novo Nordisk A/SNULLCompleted20 Years70 YearsAll35Phase 1Denmark;Sweden
25NCT01514500
(ClinicalTrials.gov)
January 16, 201213/1/2012First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy SubjectsFirst Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy SubjectsGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children;HealthyDrug: somapacitan;Drug: placebo (somapacitan)Novo Nordisk A/SNULLCompleted20 Years45 YearsMale105Phase 1Germany
26EUCTR2018-000231-27-IE
(EUCTR)
26/11/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLNA Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
27EUCTR2018-000231-27-FR
(EUCTR)
25/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLNA Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited 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
28EUCTR2018-000231-27-NO
(EUCTR)
14/11/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA 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/SNULLNAFemale: yes
Male: yes
192Phase 3Russian 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