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

  
19 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2015-002337-22-IT
(EUCTR)
24/05/201608/06/2021Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: Macimorelin acetate
Trade Name: Humalog Mix50 100 U/ml sospensione iniettabile
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: Insulin
AETERNA ZENTARIS GMBHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy
2EUCTR2015-002337-22-PL
(EUCTR)
12/04/201601/02/2016Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom
3EUCTR2015-002337-22-DE
(EUCTR)
19/01/201609/11/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
4EUCTR2015-002337-22-AT
(EUCTR)
10/12/201530/10/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
5EUCTR2015-002337-22-GB
(EUCTR)
08/12/201528/10/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
6NCT02558829
(ClinicalTrials.gov)
December 3, 201521/9/2015Validation of Macimorelin as a Test for Adult Growth Hormone DeficiencyConfirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT)Growth Hormone Deficiency With Pituitary AnomaliesDrug: Macimorelin;Drug: InsulinAEterna ZentarisNULLCompleted18 Years65 YearsAll157Phase 3United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom
7EUCTR2010-020742-10-GB
(EUCTR)
09/05/201104/11/2010Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
8NCT01804413
(ClinicalTrials.gov)
March 201118/2/2013Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone DeficiencyEffects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot StudyAdults Growth Hormone Deficiency.Drug: Pegvisomant;Drug: Regular insulinOregon Health and Science UniversityAarhus University HospitalRecruiting21 Years55 YearsBoth10N/AUnited States
9EUCTR2010-020742-10-SE
(EUCTR)
23/02/201119/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
10EUCTR2010-020742-10-FI
(EUCTR)
10/01/201122/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
11EUCTR2010-019296-30-GB
(EUCTR)
18/05/201016/04/2010A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degree relatives. - ALS deficiency: insulin resistance, bone strength & response to rhIGF1 ALS (acid label subunit) deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth Hormone Deficiency
Trade Name: INCRELEX
Product Name: Increlex
University Hospital Birmingham NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
12EUCTR2009-016783-37-SE
(EUCTR)
07/01/201016/10/2009The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GHThe Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH Growth hormone deficiency in adultsProduct Name: Genotropin, Genotropin MiniQuick
Product Code: H01AC01
INN or Proposed INN: recombinant human growth hormone
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden
13NCT00646815
(ClinicalTrials.gov)
March 200819/2/2008Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyInsulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone (genotropin)University of AarhusAarhus University HospitalCompleted18 Years60 YearsBoth24N/ADenmark
14NCT00491582
(ClinicalTrials.gov)
July 200725/6/2007The Effects of Growth Hormone (GH) on Lipid DepotsThe Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin ResistanceGrowth Hormone DeficiencyDrug: Growth hormone replacement therapy in growth hormone deficient patients only.University Hospital Inselspital, BerneSwiss National Science FoundationCompleted18 Years80 YearsBoth34N/ASwitzerland
15EUCTR2005-004316-73-GB
(EUCTR)
23/08/200612/12/2005The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivityThe effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan)Product Name: strontium ranelate
Product Code: strontium ranelate
INN or Proposed INN: strontium ranelate
Other descriptive name: N/A
Product Name: Phosphate sandoz
Product Code: phosphate sandoz
INN or Proposed INN: phosphate sandoz
Other descriptive name: N/A
Product Name: growth hormone
Product Code: growth hormone
INN or Proposed INN: growth hormone
Other descriptive name: N/A
Royal Liverpool University hospitalNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
16NCT00517062
(ClinicalTrials.gov)
January 200615/8/2007Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production RatesEffects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient AdultsGrowth Hormone DeficiencyDrug: Growth hormone (Genotropin);Drug: PlaceboOregon Health and Science UniversityNULLCompleted18 Years75 YearsBoth16Phase 0United States
17NCT00468624
(ClinicalTrials.gov)
December 20042/5/2007Effect of Pegvisomant on GH/IGF-I Relationship in GHDA Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD)Severe Adult Growth Hormone DeficiencyDrug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limbChristie Hospital NHS Foundation TrustNULLTerminated18 Years70 YearsBothN/AUnited Kingdom
18NCT00459940
(ClinicalTrials.gov)
September 200412/4/2007The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD PatientsCan Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists?Growth Hormone DeficiencyDrug: PioglitazoneUniversity of AarhusNULLCompleted19 Years71 YearsMale20N/ADenmark
19NCT00929799
(ClinicalTrials.gov)
November 200329/6/2009Growth Hormone and Glucose MetabolismEffects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: recombinant human Growth Hormone (Genotropin® )Charite University, Berlin, GermanyNULLCompleted18 YearsN/ABoth6Phase 4Germany