PEG-liposomal Prednisolone Sodium Phosphate ( DrugBank: Prednisolone, Phosphate )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎4
97潰瘍性大腸炎2

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-013884-21-PL
(EUCTR)
20/05/201013/01/2010A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Germany;Belgium;Poland
2NCT01039103
(ClinicalTrials.gov)
December 200920/12/2009Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated SyndromeDrug: PEG-liposomal prednisolone sodium phosphate;Drug: MethylprednisoloneGalapagos NVNULLTerminated18 Years65 YearsBoth15Phase 2Belgium;Germany;Poland
3EUCTR2009-013884-21-DE
(EUCTR)
18/11/200909/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Poland;Belgium;Germany
4EUCTR2009-013884-21-BE
(EUCTR)
13/11/200910/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Poland;Belgium;Germany

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-020448-37-NL
(EUCTR)
21/12/201116/09/2010Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. Active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Enceladus PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Belgium;Netherlands
2EUCTR2010-020448-37-BE
(EUCTR)
10/12/201022/12/2010Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. Active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Enceladus PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Belgium;Netherlands