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 | EUCTR2015-002586-39-BE (EUCTR) | 19/01/2017 | 14/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Switzerland;Italy;United Kingdom;Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany | ||
| 2 | EUCTR2015-002586-39-GB (EUCTR) | 18/10/2016 | 19/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 3 | EUCTR2015-002586-39-PT (EUCTR) | 03/10/2016 | 06/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | France;United States;Portugal;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 4 | EUCTR2015-002586-39-HU (EUCTR) | 20/09/2016 | 12/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 5 | EUCTR2015-002586-39-FR (EUCTR) | 13/09/2016 | 21/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;United States;France;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 6 | EUCTR2015-002586-39-DE (EUCTR) | 03/08/2016 | 29/06/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 7 | EUCTR2015-002586-39-IT (EUCTR) | 27/07/2016 | 06/02/2018 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride Product Code: / INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride Product Code: / INN or Proposed INN: TERGURIDE HYDROGENMALEATE Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL Product Name: Metoclopramide Product Code: / INN or Proposed INN: METOCLOPRAMIDE Other descriptive name: METOCLOPRAMIDE | MEDAC GMBH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 8 | EUCTR2009-017869-27-DE (EUCTR) | 23/09/2010 | 14/07/2010 | A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis. | A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis. | Diffuse scleroderma MedDRA version: 12.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma | Product Name: Terguride Product Code: PR1 INN or Proposed INN: Terguride Other descriptive name: transdihydrolisuride | University Hospital Zurich | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 14 | Germany |