Norditropin®    (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52

78. 下垂体前葉機能低下症 [臨床試験数:462,薬物数:346(DrugBank:45),標的遺伝子数:41,標的パスウェイ数:80
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
52 / 462 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04614337
(ClinicalTrials.gov)
October 7, 202026/10/2020Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone DeficiencyDrug: LUM-201;Drug: rhGH Norditropin® FlexPro® pen (34 µg/kg)Lumos PharmaNULLRecruiting3 Years10 YearsAll80Phase 2United States
2EUCTR2018-000231-27-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
3EUCTR2018-000231-27-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
4EUCTR2018-000231-27-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
5EUCTR2018-000231-27-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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-000231-27-SI
(EUCTR)
17/07/201914/06/2019A 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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192Phase 3United States;Slovenia;Thailand;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Algeria;Japan;Korea, Republic of
7NCT03972345
(ClinicalTrials.gov)
June 21, 201931/5/2019Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)Growth Hormone Deficiency in Children;Born Small for Gestational AgeDrug: Norditropin® FlexPro®Novo Nordisk A/SNULLEnrolling by invitationN/A15 YearsAll750Germany
8EUCTR2018-000231-27-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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192Phase 3United 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
9EUCTR2018-000231-27-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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192Phase 3United 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
10NCT03811535
(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 recruiting2 Years11 YearsAll192Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-000231-27-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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192Phase 3United States;Slovenia;Thailand;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Algeria;Japan;Korea, Republic of
12NCT04513171
(ClinicalTrials.gov)
December 26, 20187/8/2020Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency ChildrenA Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.Growth Hormone DeficiencyDrug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: NorditropinXiamen Amoytop Biotech Co., Ltd.Tongji HospitalRecruiting3 Years11 YearsAll400Phase 2;Phase 3China
13NCT03075644
(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
14NCT02616562
(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 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 DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: Norditropin® FlexPro® penNovo Nordisk A/SNULLRecruitingN/A17 YearsAll74Phase 2United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine
15EUCTR2015-000531-32-DE
(EUCTR)
14/03/201620/11/2015A 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 hormoneA 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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-000531-32-BE
(EUCTR)
17/02/201630/11/2015A 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 hormoneA 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/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden
17EUCTR2015-000531-32-SE
(EUCTR)
14/01/201604/11/2015A 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 hormoneA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
18EUCTR2015-000531-32-SI
(EUCTR)
15/12/201511/11/2015A 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 hormoneA 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]
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
19EUCTR2015-000531-32-AT
(EUCTR)
10/12/201503/11/2015A 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 hormoneA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
20EUCTR2013-002892-16-LV
(EUCTR)
12/10/201531/07/2015A 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 deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-002892-16-LT
(EUCTR)
30/09/201527/07/2015A 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 deficiencyA 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/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
22NCT02382939
(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
23EUCTR2014-000290-39-GB
(EUCTR)
30/01/201522/01/2015A 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 deficiencyA 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/SNULLNot RecruitingFemale: yes
Male: yes
90Phase 3European Union;Denmark;Japan;United Kingdom;Sweden
24EUCTR2014-000290-39-DK
(EUCTR)
22/01/201522/01/2015A 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 deficiencyA 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/SNULLNot RecruitingFemale: yes
Male: yes
90European Union;Denmark;United Kingdom;Japan;Sweden
25EUCTR2013-002892-16-DE
(EUCTR)
22/12/201429/09/2014A 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 deficiencyA 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/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-002892-16-GB
(EUCTR)
20/11/201424/09/2014A 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 deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
27EUCTR2014-000290-39-SE
(EUCTR)
07/11/201407/10/2014A 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 deficiencyA 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/SNULLNot RecruitingFemale: yes
Male: yes
90European Union;Denmark;United Kingdom;Japan;Sweden
28NCT02229851
(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
29EUCTR2013-002892-16-SE
(EUCTR)
07/10/201403/09/2014A 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 deficiencyA 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/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
30EUCTR2013-000013-20-ES
(EUCTR)
02/01/201410/01/2014A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone 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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Austria;Israel;Norway;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-000013-20-SE
(EUCTR)
20/12/201312/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone 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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
32EUCTR2013-000013-20-BE
(EUCTR)
17/12/201311/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone 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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
33EUCTR2013-000013-20-AT
(EUCTR)
16/12/201311/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone 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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
34NCT01973244
(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
35EUCTR2013-000013-20-SI
(EUCTR)
09/12/201320/09/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone 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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2010-018586-39-DK
(EUCTR)
01/06/201012/05/2010Diurnal variation of exogenous peptides - Gh Puls/Jurgita IDiurnal variation of exogenous peptides - Gh Puls/Jurgita I Adults with growth hormone disease (AGHD).Trade Name: Norditropin® SimpleXx® 5 mg/1.5ml
Other descriptive name: GROWTH HORMONE
Trade Name: Norditropin® SimpleXx® 5 mg/1.5ml
Other descriptive name: GROWTH HORMONE
Medical Department M (Endocrinology & Diabetes)NULLNot RecruitingFemale: yes
Male: yes
8Denmark
37NCT01109017
(ClinicalTrials.gov)
October 200919/4/2010Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone DeficiencyA Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHDGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth387N/AJapan
38NCT00934063
(ClinicalTrials.gov)
July 20092/7/2009An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)Growth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropin;Other: No treatment givenNovo Nordisk A/SNULLCompleted18 YearsN/ABoth121N/AGermany
39NCT00960128
(ClinicalTrials.gov)
April 1, 200613/8/2009Observational Prospective Study on Patients Treated With Norditropin®NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll21249N/AArgentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro
40NCT01604161
(ClinicalTrials.gov)
May 200521/5/2012Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner SyndromeA Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth2016N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00567385
(ClinicalTrials.gov)
March 10, 200330/11/2007Liquid Somatropin Formulation in Children With Growth Hormone DeficiencyAn Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years18 YearsAll176Phase 4Turkey
42NCT01009905
(ClinicalTrials.gov)
June 24, 20025/11/2009An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth HormoneGrowth Hormone Disorder;Pituitary Dwarfism;HypopituitarismDrug: somatropinNovo Nordisk A/SNULLCompletedN/A18 YearsAll22960N/AUnited States
43NCT00184678
(ClinicalTrials.gov)
February 200213/9/2005Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone DeficiencyEffect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years25 YearsAll161Phase 3Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom
44NCT01502124
(ClinicalTrials.gov)
May 8, 200129/12/2011Safety and Efficacy of Somatropin in Children With Growth Hormone DeficiencyNorditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years17 YearsAll78Phase 3United States
45NCT00931476
(ClinicalTrials.gov)
April 6, 200030/6/2009A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of SomatropinA Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)Growth Hormone Disorder;Adult Growth Hormone Deficiency;HealthyDrug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted20 Years50 YearsMale86Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01562834
(ClinicalTrials.gov)
October 21, 199822/3/2012Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult PatientsRandomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult PatientsGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years50 YearsAll22Phase 4France
47EUCTR2018-000231-27-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 3Serbia;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
48EUCTR2018-000231-27-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]
Novo Nordisk A/SNULLNA Female: yes
Male: yes
192Phase 3United 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
49EUCTR2018-000231-27-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]
Novo Nordisk A/SNULLNA Female: yes
Male: yes
192Phase 3Serbia;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
50EUCTR2018-000231-27-PL
(EUCTR)
04/02/2020A 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/SNULLNAFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2013-000013-20-FR
(EUCTR)
25/09/2015A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone 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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
32Phase 1France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
52EUCTR2018-000231-27-DE
(EUCTR)
11/02/2019A 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/SNULLNAFemale: 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