SOMATROPIN FOR INJECTION ( DrugBank: Somatropin )
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 | 11 |
78. 下垂体前葉機能低下症
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 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 | EUCTR2018-000918-38-BG (EUCTR) | 16/07/2019 | 23/05/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | 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: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 2 | EUCTR2018-000918-38-SK (EUCTR) | 11/07/2019 | 11/02/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | 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: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 3 | EUCTR2018-000918-38-CZ (EUCTR) | 27/06/2019 | 20/03/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | 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: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 4 | EUCTR2018-000918-38-GB (EUCTR) | 16/05/2019 | 27/11/2018 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | 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: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 5 | EUCTR2016-003874-42-GR (EUCTR) | 20/12/2017 | 21/11/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal 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: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand | ||
| 6 | EUCTR2016-003874-42-GB (EUCTR) | 04/09/2017 | 03/01/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal 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: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus | ||
| 7 | EUCTR2016-003874-42-DE (EUCTR) | 04/08/2017 | 01/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children 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] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 8 | EUCTR2016-003874-42-ES (EUCTR) | 18/05/2017 | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children 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] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 9 | EUCTR2016-003874-42-BG (EUCTR) | 26/04/2017 | 13/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal 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: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | ||
| 10 | EUCTR2016-003874-42-PL (EUCTR) | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal 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: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | |||
| 11 | EUCTR2016-003874-42-FR (EUCTR) | 06/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal 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: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand |