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

  
15 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2013-000013-20-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/SNULLNot RecruitingFemale: yes
Male: yes
32Phase 1France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Belgium;Spain;Austria;Israel;Norway;Switzerland;Sweden
2EUCTR2013-000013-20-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
3EUCTR2013-000013-20-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
4EUCTR2013-000013-20-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
5EUCTR2013-000013-20-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
6NCT01090778
(ClinicalTrials.gov)
October 201022/3/2010Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Norditropin SimpleXx (growth hormone)Aarhus University HospitalNovo Nordisk A/SCompleted18 Years75 YearsBoth8Phase 2Denmark
7EUCTR2010-019374-32-SI
(EUCTR)
13/09/201004/06/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Omnitrop
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: ecombinanat DNA-derived human growth h
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
8EUCTR2010-019374-32-HU
(EUCTR)
13/09/201018/05/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Saizen
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
9EUCTR2010-019374-32-SK
(EUCTR)
15/07/201014/05/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Saizen
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
10EUCTR2005-004478-26-SE
(EUCTR)
13/01/200628/10/2005Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines.Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours.Trade Name: Norditropin SimpleXx
Product Name: Norditropin SimpleXx
INN or Proposed INN: somatropin
Karolinska universitetssjukhusetNULLNot RecruitingFemale: yes
Male: yes
Sweden
11EUCTR2004-004292-11-SE
(EUCTR)
06/10/200505/08/2005Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCODiscontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO This is a study in growth hormone deficient adult patients on stable growth hormone therapy of discountinuate growth hormone (GH) for 4 months in double blinded crossover, palcebo/controlled, randomised study design. Trade Name: Norditropin SimplexX (5mg/1,5 ml) (INN:somatropin)
Product Name: Norditropin SimplexX
Product Code: NA
Endocrine Department, Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden
12EUCTR2004-004835-72-GB
(EUCTR)
12/01/200517/02/2005A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) Growth hormone deficiency in adult lifeTrade Name: Norditropin SimpleXx 5mg/1.5ml
Product Name: Norditropin SimpleXx 5mg/1.5ml
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone, GH
University of BirminghamUniversity Hospital Birmingham Foundation NHS TrustNot RecruitingFemale: yes
Male: yes
200United Kingdom
13NCT01580605
(ClinicalTrials.gov)
July 17, 200313/4/2012French National Registry of Adults With Growth Hormone Deficiency Treated With SomatropinProspective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was StartedGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll331France
14NCT01563926
(ClinicalTrials.gov)
October 23, 200023/3/2012Evaluating Acceptance of New Liquid 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 Children;Genetic Disorder;Turner SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll168Phase 3Israel
15EUCTR2013-000013-20-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