Sodium Chloride solution ( DrugBank: Sodium chloride, Chloride )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症1
13多発性硬化症/視神経脊髄炎1
51全身性強皮症1
228閉塞性細気管支炎8

11. 重症筋無力症


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02950155
(ClinicalTrials.gov)
October 16, 201628/10/2016A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia GravisA Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG)Generalized Myasthenia GravisDrug: Rituximab;Drug: Sodium Chloride solutionFredrik PiehlNULLActive, not recruiting18 YearsN/AAll47Phase 3Sweden

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
1NCT02746744
(ClinicalTrials.gov)
May 201618/4/2016RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.Multiple Sclerosis, Relapsing-RemittingDrug: Rituximab;Drug: Dimethyl fumarate;Drug: Sodium Chloride solutionAnders SvenningssonNULLCompleted18 Years50 YearsAll200Phase 3Sweden

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 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
1EUCTR2019-004400-35-NO
(EUCTR)
24/06/202004/03/2020The ReSScue trial. Aiming to Reduce disease-related gastro-intestinal symptoms in patients with Systemic Sclerosis by repeat intestinal infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Phase II, randomized, double-blinded placebo-controlled 12 week study followed by a 14 week blinded extension with open label oral ACHIM capsules.The ReSScue trial. Aiming to Reduce disease-related gastro-intestinal symptoms in patients with Systemic Sclerosis by repeat intestinal infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Phase II, randomized, double-blinded placebo-controlled 12 week study followed by a 14 week blinded extension with open label oral ACHIM capsules. Systemic sclerosis (SSc) is a rare, complex, multi-organ disorder characterized by immune-mediated inflammation, progressive organ fibrosis and vascular pathology leading to small vessel obliteration. Gastrointestinal tract (GIT) affliction occurs in 9/10 SSc patients, involves all parts of the GIT and impairs key GIT functions such as motility, absorption and sphincter control. GIT symptoms impact quality of life in SSc, and severe GIT afflictions are among the leading causes of death in SSc.
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ACHIM capsules
INN or Proposed INN: Sodium chloride solution
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Product Name: ACHIM
INN or Proposed INN: Sodium chloride solution
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Oslo University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2Norway

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-003800-73-BE
(EUCTR)
14/09/201008/01/2009A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
2EUCTR2008-003800-73-ES
(EUCTR)
22/07/201026/05/2010A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonarA phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar Prevention of bronchiolitis obliterans syndrome in lung transplantPrevención del sindrome de bronquiolitis obliterante en transplante pulmonar
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina/ Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina / Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Solucion de cloruro de sodio Sodium Chloride Solution
Product Code: Solvente Cloruro de Sodio Sodium Chloride Solvent
Other descriptive name: Cloruro de sodio
Product Name: Solucion de Cloruro de Sodio
Product Code: Solvente de Cloruro de Sodio
Other descriptive name: Cloruro de Sodio
Pari Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Belgium;Spain;Denmark;Austria;Germany;United Kingdom
3EUCTR2008-003800-73-DK
(EUCTR)
13/04/201018/08/2009A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsA phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Pari Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Spain;Belgium;Austria;Denmark;Germany;United Kingdom
4EUCTR2008-003800-73-GB
(EUCTR)
27/08/200907/01/2009A phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsA phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Pari Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Belgium;Denmark;Austria;Germany;United Kingdom
5EUCTR2008-003800-73-DE
(EUCTR)
14/07/200929/12/2008A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase II, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
6EUCTR2008-003800-73-AT
(EUCTR)
08/07/200911/05/2009A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
7EUCTR2008-003801-15-GB
(EUCTR)
26/02/200924/11/2010A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride
PARIPharma GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2United Kingdom
8EUCTR2008-003801-15-BE
(EUCTR)
08/01/2009A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride
PARIPharma GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Belgium;United Kingdom