Dexamethasone sodium phosphate ph. eur. (DrugBank: Dexamethasone, Phosphate)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
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65 | 原発性免疫不全症候群 | 9 |
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 |
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1 | EUCTR2018-000338-36-NO (EUCTR) | 06/11/2020 | 04/02/2020 | Not Applicable | Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 155 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Tunisia;Germany;Norway;United Kingdom;Italy;India | ||
2 | EUCTR2018-000338-36-GB (EUCTR) | 27/05/2020 | 20/01/2020 | Not Applicable | Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT, version 5.0 | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 51 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India | ||
3 | EUCTR2018-000338-36-DE (EUCTR) | 20/09/2018 | 21/06/2018 | Not Applicable | Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 155 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India | ||
4 | EUCTR2018-000338-36-ES (EUCTR) | 31/05/2018 | 05/04/2018 | Not Applicable | Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 20.1;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 61 | Phase 3 | United States;Poland;Belgium;Spain;Australia;Israel;Norway;Germany;Italy;United Kingdom;India | ||
5 | EUCTR2015-005241-31-IT (EUCTR) | 02/11/2016 | 28/02/2018 | n/a | A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - EDS in Ataxia Telangiectasia Patients - IEDAT-02 | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 20.1;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexametasone Fosfato Sodico INN or Proposed INN: Dexametasone Fosfato Sodico Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | ERYDEL S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Costa Rica;Turkey;Israel;Italy;United Kingdom;Belgium;Poland;Australia;Tunisia;Germany;Norway | ||
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 | EUCTR2015-005241-31-DE (EUCTR) | 14/09/2016 | 27/05/2016 | n/a | A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - Ataxia Telangiectasia - Treatment with EryDex SysTem - ATTEST | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 175 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Norway;Germany;United Kingdom;Italy;India | ||
7 | EUCTR2015-005241-31-ES (EUCTR) | 31/05/2016 | 09/06/2016 | n/a | A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - EDS in Ataxia Telangiectasia Patients - IEDAT-02 | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 19.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Costa Rica;Turkey;Israel;United Kingdom;Italy;Belgium;Poland;Australia;Tunisia;Germany;Norway | ||
8 | EUCTR2018-000338-36-PL (EUCTR) | 06/11/2018 | Not Applicable | Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | NA | Female: yes Male: yes | 155 | Phase 3 | United States;Spain;Belgium;Poland;Australia;Tunisia;Norway;Germany;United Kingdom;Italy;India | |||
9 | EUCTR2015-005241-31-PL (EUCTR) | 01/07/2016 | n/a | A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - EDS in Ataxia Telangiectasia Patients - IEDAT-02 | Patient with neurological symptoms of Ataxia Telangiectasia MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexamethasone sodium phosphate INN or Proposed INN: Dexamethasone sodium phosphate Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR. | EryDel S.p.A. | NULL | NA | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Costa Rica;Turkey;Israel;United Kingdom;Italy;India;Poland;Belgium;Australia;Norway;Tunisia;Germany |