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.
| 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 | EUCTR2005-000384-26-FR (EUCTR) | 12/10/2015 | 04/10/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | |||
| 2 | EUCTR2006-002278-24-SE (EUCTR) | 15/05/2007 | 05/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 3 | EUCTR2006-002278-24-GB (EUCTR) | 02/05/2007 | 23/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | |||
| 4 | EUCTR2006-002278-24-SK (EUCTR) | 20/04/2007 | 22/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 5 | EUCTR2006-002278-24-FR (EUCTR) | 13/04/2007 | 24/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 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 |
| 6 | EUCTR2006-002278-24-IT (EUCTR) | 05/04/2007 | 16/12/2008 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO | Growth hormone deficiency MedDRA version: 9.1;Level: HLT;Classification code 10002701;Term: Anterior pituitary hypofunction | Product Name: LB03002 INN or Proposed INN: sustained release growth hormone | BIOPARTNERS GMBH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 7 | EUCTR2006-002278-24-AT (EUCTR) | 05/01/2007 | 10/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 8 | EUCTR2005-000346-36-LT (EUCTR) | 29/12/2006 | 24/10/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania | ||
| 9 | EUCTR2006-002278-24-CZ (EUCTR) | 14/12/2006 | 08/09/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | ||
| 10 | EUCTR2006-002278-24-ES (EUCTR) | 13/12/2006 | 10/03/2010 | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 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 |
| 11 | EUCTR2006-002278-24-DE (EUCTR) | 06/10/2006 | 15/08/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 12 | NCT00596037 (ClinicalTrials.gov) | August 2006 | 7/1/2008 | Treatment of Adults With Growth Hormone Deficiency | A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency | Pituitary Disorders;Adult Growth Hormone Deficiency | Drug: Growth hormone - LB03002 | LG Life Sciences | BioPartners GmbH | Completed | 23 Years | 70 Years | Both | 136 | Phase 3 | United States |
| 13 | NCT00294619 (ClinicalTrials.gov) | April 2006 | 20/2/2006 | Treatment of Adults With Growth Hormone Deficiency | A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency. | Pituitary Disorders;Adult Growth Hormone Deficiency | Drug: growth hormone | LG Life Sciences | BioPartners GmbH | Completed | 23 Years | 70 Years | Both | 147 | Phase 3 | United States |
| 14 | EUCTR2005-000384-26-IT (EUCTR) | 23/03/2006 | 02/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency | Growth hormone deficiency in adult MedDRA version: 6.1;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: Somatropin | BIOPARTNERS GMBH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Italy;Sweden | |||
| 15 | EUCTR2005-000384-26-DE (EUCTR) | 20/12/2005 | 02/06/2006 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;Spain;Sweden | ||
| 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 |
| 16 | EUCTR2005-000384-26-AT (EUCTR) | 10/11/2005 | 10/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | BioPartners | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 17 | EUCTR2005-000384-26-SK (EUCTR) | 27/10/2005 | 19/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 18 | EUCTR2005-000384-26-GB (EUCTR) | 21/10/2005 | 17/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | |||
| 19 | EUCTR2005-000384-26-CZ (EUCTR) | 30/09/2005 | 08/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 20 | EUCTR2005-000346-36-FI (EUCTR) | 22/09/2005 | 30/05/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 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 |
| 21 | EUCTR2005-000384-26-SE (EUCTR) | 13/09/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 22 | NCT00271518 (ClinicalTrials.gov) | September 2005 | 29/12/2005 | Treatment of Children With Insufficient Secretion of Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone | Growth Hormone Deficiency (GHD) | Drug: growth hormone (somatropin) | LG Life Sciences | BioPartners GmbH | Active, not recruiting | 3 Years | 11 Years | Both | 144 | Phase 3 | United States |
| 23 | EUCTR2005-000384-26-ES (EUCTR) | 22/08/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 138 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 24 | EUCTR2005-000346-36-SE (EUCTR) | 18/08/2005 | 16/06/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 25 | EUCTR2005-000346-36-DE (EUCTR) | 16/08/2005 | 06/06/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 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 |
| 26 | NCT00600808 (ClinicalTrials.gov) | June 2003 | 23/7/2007 | Sustained Release Formulation of Somatropin (rDNA Origin)for Injection | A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency. | Growth Hormone Deficiency | Drug: BPLG-003 | BioPartners GmbH | LG Life Sciences | Completed | 4 Years | 10 Years | Both | 51 | Phase 2;Phase 3 | NULL |