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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-002337-22-IT (EUCTR) | 24/05/2016 | 08/06/2021 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GMBH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2015-002337-22-PL (EUCTR) | 12/04/2016 | 01/02/2016 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not 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): no | Serbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2015-002337-22-DE (EUCTR) | 19/01/2016 | 09/11/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2015-002337-22-AT (EUCTR) | 10/12/2015 | 30/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2015-002337-22-GB (EUCTR) | 08/12/2015 | 28/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not 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): no | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 6 | NCT02558829 (ClinicalTrials.gov) | December 3, 2015 | 21/9/2015 | Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency | Confirmatory 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 Anomalies | Drug: Macimorelin;Drug: Insulin | AEterna Zentaris | NULL | Completed | 18 Years | 65 Years | All | 157 | Phase 3 | United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom |
| 7 | EUCTR2010-020742-10-GB (EUCTR) | 09/05/2011 | 04/11/2010 | 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. | 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 8 | NCT01804413 (ClinicalTrials.gov) | March 2011 | 18/2/2013 | Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency | Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study | Adults Growth Hormone Deficiency. | Drug: Pegvisomant;Drug: Regular insulin | Oregon Health and Science University | Aarhus University Hospital | Recruiting | 21 Years | 55 Years | Both | 10 | N/A | United States |
| 9 | EUCTR2010-020742-10-SE (EUCTR) | 23/02/2011 | 19/11/2010 | Comparison 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 10 | EUCTR2010-020742-10-FI (EUCTR) | 10/01/2011 | 22/11/2010 | Comparison 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 Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 11 | EUCTR2010-019296-30-GB (EUCTR) | 18/05/2010 | 16/04/2010 | A 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 12 | EUCTR2009-016783-37-SE (EUCTR) | 07/01/2010 | 16/10/2009 | The 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 | The 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 adults | Product Name: Genotropin, Genotropin MiniQuick Product Code: H01AC01 INN or Proposed INN: recombinant human growth hormone | Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 13 | NCT00646815 (ClinicalTrials.gov) | March 2008 | 19/2/2008 | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone (genotropin) | University of Aarhus | Aarhus University Hospital | Completed | 18 Years | 60 Years | Both | 24 | N/A | Denmark |
| 14 | NCT00491582 (ClinicalTrials.gov) | July 2007 | 25/6/2007 | The Effects of Growth Hormone (GH) on Lipid Depots | The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance | Growth Hormone Deficiency | Drug: Growth hormone replacement therapy in growth hormone deficient patients only. | University Hospital Inselspital, Berne | Swiss National Science Foundation | Completed | 18 Years | 80 Years | Both | 34 | N/A | Switzerland |
| 15 | EUCTR2005-004316-73-GB (EUCTR) | 23/08/2006 | 12/12/2005 | The 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 | The 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 hospital | NULL | Not 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): yes | United Kingdom | ||
| 16 | NCT00517062 (ClinicalTrials.gov) | January 2006 | 15/8/2007 | Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates | Effects 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 Adults | Growth Hormone Deficiency | Drug: Growth hormone (Genotropin);Drug: Placebo | Oregon Health and Science University | NULL | Completed | 18 Years | 75 Years | Both | 16 | Phase 0 | United States |
| 17 | NCT00468624 (ClinicalTrials.gov) | December 2004 | 2/5/2007 | Effect of Pegvisomant on GH/IGF-I Relationship in GHD | A 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 Deficiency | Drug: 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 limb | Christie Hospital NHS Foundation Trust | NULL | Terminated | 18 Years | 70 Years | Both | N/A | United Kingdom | |
| 18 | NCT00459940 (ClinicalTrials.gov) | September 2004 | 12/4/2007 | The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients | Can Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists? | Growth Hormone Deficiency | Drug: Pioglitazone | University of Aarhus | NULL | Completed | 19 Years | 71 Years | Male | 20 | N/A | Denmark |
| 19 | NCT00929799 (ClinicalTrials.gov) | November 2003 | 29/6/2009 | Growth Hormone and Glucose Metabolism | Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: recombinant human Growth Hormone (Genotropin® ) | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | Both | 6 | Phase 4 | Germany |