51. 全身性強皮症 Scleroderma Clinical trials / Disease details
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. | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004400-35-NO (EUCTR) | 24/06/2020 | 04/03/2020 | 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. | 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 Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | Norway | ||
| 2 | EUCTR2017-000372-29-IT (EUCTR) | 25/09/2018 | 27/01/2021 | Clinical Trial to evaluate efficacy and eafety of Lenabasum in for the diffuse dutaneous systemic sclerosis, a disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis | Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Lenabasum 5mg Powder in Capsule Product Code: [JBT-101] INN or Proposed INN: lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum 20 mg Powder in Capsule Product Code: [JBT-101] Other descriptive name: resunab, ajulemic acid, anabasum | CORBUS PHARMACEUTICALS, INC | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 3 | EUCTR2014-002796-28-NL (EUCTR) | 12/04/2016 | 23/04/2015 | Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? | The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS | Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | University Medical Center Groningen (UMCG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 4 | EUCTR2013-004596-12-IT (EUCTR) | 22/01/2014 | 13/12/2013 | Infusion at home ,using a pump device, of a drug that dilates peripheral blood vessels to treat patients affected by a disease named Systemic sclerosis, with manifestations caused by a reduced blood flow in hands and feet. | HOME INFUSION THERAPY WITH ILOPROST USING A PORTABLE SYRINGE PUMP FOR THE TREATMENT OF PERIPHERAL ULCERS AND RAYNAUD'S PHENOMENON IN SYSTEMIC SCLEROSIS. - iloporta | Raynaud's phenomenon and acral ulcers in systemic sclerosis;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Endoprost Product Name: Endoprost | Azienda ospedaliera universitaria Ospedali Riuniti | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 5 | EUCTR2010-024005-13-GB (EUCTR) | 11/03/2011 | 30/12/2010 | A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature. | Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino | Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome) MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ORM-12741 Product Code: ORM-12741 Other descriptive name: alpha-2C AR antagonist Product Name: ORM-12741 Product Code: ORM-12741 Other descriptive name: Alpha-2C AR antagonist | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 6 | EUCTR2009-018194-31-GB (EUCTR) | 03/11/2010 | 18/03/2010 | Topical Amlodipine in Raynaud's Phenomenon | Topical Amlodipine in Raynaud's Phenomenon | The medical conditions under investigation in this trial are as follows:1] Primary Raynaud's Phenomenon2] Systemic Sclerosis (SSc) - otherwise known an Seconday Raynaud's Phenomenon.Raynaud's phenomenon is a disorder that affects the blood vessels in the fingers, toes, ears, and nose. This disorder is characterized by episodic attacks, called vasospastic attacks, that cause the blood vessels in the digits (fingers and toes) to constrict (narrow). | Product Name: Amlodipine Gel Product Code: AM-01 | Pharmarama International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | United Kingdom | |||
| 7 | NCT00740285 (ClinicalTrials.gov) | April 2004 | 19/8/2008 | Effectiveness and Safety of Lidocaine for Scleroderma | Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial | Scleroderma | Drug: Lidocaine 2% without vessel constrictor;Other: Placebo - physiological solution 0,9% | Federal University of São Paulo | NULL | Completed | 18 Years | 60 Years | Both | 26 | Phase 2/Phase 3 | Brazil |