DEXAMETHASONE SODIUM PHOSPHATE ( DrugBank: Dexamethasone, Phosphate )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
65原発性免疫不全症候群14
70広範脊柱管狭窄症1
96クローン病2

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000338-36-IT
(EUCTR)
12/05/202104/06/2021Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study.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 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 (soluzione 25mg/ml)
Product Code: [Dexamethasone sodium phosphate]
INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE
ERYDEL S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
155Phase 3United States;Spain;Poland;Belgium;Australia;Norway;Germany;Tunisia;United Kingdom;Italy;India
2EUCTR2018-000338-36-NO
(EUCTR)
06/11/202004/02/2020Not ApplicableOpen-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
155Phase 3United States;Spain;Poland;Belgium;Australia;Tunisia;Germany;Norway;United Kingdom;Italy;India
3EUCTR2018-000338-36-GB
(EUCTR)
27/05/202020/01/2020Not ApplicableOpen-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
51Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India
4EUCTR2018-000338-36-DE
(EUCTR)
20/09/201821/06/2018Not ApplicableOpen-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India
5EUCTR2018-000338-36-BE
(EUCTR)
23/08/201828/06/2018Not ApplicableOpen-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.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Spain;Belgium;Australia;Israel;Germany;India
6EUCTR2018-000338-36-ES
(EUCTR)
31/05/201805/04/2018Not ApplicableOpen-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
61Phase 3United States;Poland;Belgium;Spain;Australia;Israel;Norway;Germany;Italy;United Kingdom;India
7NCT02770807
(ClinicalTrials.gov)
March 2, 20172/5/2016EDS in Ataxia Telangiectasia PatientsMulti-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients With Ataxia TelangiectasiaNervous System Disease;Genetic SyndromeDrug: EDS-EP dose range of ~5-10 mg DSP/infusion;Drug: EDS-EP dose range of ~14-22 mg DSP/infusion;Drug: PlaceboErydelNULLCompleted6 YearsN/AAll175Phase 3United States;Australia;Belgium;Germany;India;Israel;Italy;Norway;Poland;Spain;Tunisia;United Kingdom
8EUCTR2015-005241-31-NO
(EUCTR)
21/11/201602/06/2016n/aA 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.NULLNot RecruitingFemale: yes
Male: yes
175Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Germany;Norway;United Kingdom;Italy;India
9EUCTR2015-005241-31-IT
(EUCTR)
02/11/201628/02/2018n/aA 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.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Tunisia;United States;Costa Rica;Spain;Turkey;Israel;Italy;United Kingdom;Belgium;Poland;Australia;Germany;Norway
10EUCTR2015-005241-31-BE
(EUCTR)
21/10/201601/06/2016n/aA 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: 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.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Germany;United Kingdom;Italy;India;Norway
11EUCTR2015-005241-31-DE
(EUCTR)
14/09/201627/05/2016n/aA 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.NULLNot RecruitingFemale: yes
Male: yes
175Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Norway;Germany;United Kingdom;Italy;India
12EUCTR2015-005241-31-ES
(EUCTR)
31/05/201609/06/2016n/aA 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.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Spain;Costa Rica;Turkey;Israel;United Kingdom;Italy;Belgium;Poland;Australia;Tunisia;Germany;Norway
13EUCTR2018-000338-36-PL
(EUCTR)
06/11/2018Not ApplicableOpen-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.NULLNAFemale: yes
Male: yes
155Phase 3United States;Spain;Belgium;Poland;Australia;Tunisia;Norway;Germany;United Kingdom;Italy;India
14EUCTR2015-005241-31-PL
(EUCTR)
01/07/2016n/aA 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.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Costa Rica;Spain;Turkey;Israel;Italy;United Kingdom;India;Poland;Belgium;Australia;Germany;Norway;Tunisia

70. 広範脊柱管狭窄症


臨床試験数 : 95 薬物数 : 169 - (DrugBank : 61) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 90
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04537026
(ClinicalTrials.gov)
June 16, 202128/8/2020Sterile Amniotic Fluid Filtrate Epidural Injection.A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis: The SAFE Trial (Improving Safety and Outcomes in the Treatment of Pain and Disability Related to Spinal Stenosis).Lumbar Spinal StenosisDrug: Amniotic Fluid Allograft;Drug: Dexamethasone sodium phosphateUniversity of UtahCell Therapy & Regenerative MedicineRecruiting18 YearsN/AAll112Phase 1/Phase 2United States

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-007329-38-ES
(EUCTR)
24/07/200924/04/2009Estudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s DiseaseEstudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease Pacientes con enfermedad de Crohn dependiente de esteroides
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
INN or Proposed INN: fosfato sodico de dexametasona
ERYDEL S.P.A.NULLNot RecruitingFemale: yes
Male: yes
184Spain;Italy
2EUCTR2008-007329-38-IT
(EUCTR)
06/02/200921/01/2009Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s DiseaseMulticenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease Patients with steroid-dependent Crohn?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
INN or Proposed INN: dexamethasone sodium phosphate
ERYDEL S.P.A.NULLNot RecruitingFemale: yes
Male: yes
184Spain;Italy