Nanocort ( DrugBank: - )


3 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
46悪性関節リウマチ2
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

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-002924-17-BE
(EUCTR)
24/02/201627/01/2016A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid ArthritisA Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Nanocort
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Trade Name: Depo Medrol
Product Name: Depo Medrol
Sun Pharma Global FZENULLNot RecruitingFemale: yes
Male: yes
330Phase 3Belgium;Netherlands
2EUCTR2015-002924-17-NL
(EUCTR)
12/11/201506/10/2015A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid ArthritisA Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Nanocort
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Trade Name: Depo Medrol
Product Name: Depo Medrol
Sun Pharma Global FZENULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Netherlands

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