36. 表皮水疱症 Epidermolysis bullosa Clinical trials / Disease details
臨床試験数 : 163 / 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
| 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 | EUCTR2018-000439-29-GB (EUCTR) | 04/06/2018 | 22/03/2018 | A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB) | A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB) | Epidermolysis Bullosa (EB) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: CCP-020 INN or Proposed INN: DIACEREIN | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 4 | Phase 1 | United States;France;Netherlands;Germany;United Kingdom | ||
| 2 | NCT03472287 (ClinicalTrials.gov) | May 18, 2018 | 14/3/2018 | To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB) | A Multi-Center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein After Maximum Use, Topical Administration of CCP-020 (Diacerein 1% Ointment) to Patients With Epidermolysis Bullosa (EB) | Epidermolysis Bullosa (EB);Epidermolysis Bullosa Simplex;Dystrophic Epidermolysis Bullosa;Junctional Epidermolysis Bullosa | Drug: Diacerein 1% Ointment | Castle Creek Pharmaceuticals, LLC | NULL | Completed | 4 Years | N/A | All | 11 | Phase 1 | United States;France;Netherlands;United Kingdom |
| 3 | EUCTR2017-003757-41-DE (EUCTR) | 19/04/2018 | 21/02/2018 | An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2017-003757-41-NL (EUCTR) | 11/04/2018 | 06/12/2017 | An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Austria;Australia;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 5 | EUCTR2017-003757-41-GB (EUCTR) | 19/02/2018 | 13/11/2017 | An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2017-003757-41-FR (EUCTR) | 07/02/2018 | 17/10/2018 | An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom | ||
| 7 | EUCTR2017-003757-41-AT (EUCTR) | 04/01/2018 | 29/11/2017 | An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 2 | France;United States;Australia;Austria;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | NCT03389308 (ClinicalTrials.gov) | December 1, 2017 | 19/12/2017 | Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex | An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa;Epidermolysis Bullosa Simplex | Drug: diacerein 1% ointment | Castle Creek Pharmaceuticals, LLC | NULL | Completed | 6 Months | 99 Years | All | 51 | Phase 2 | United States |
| 9 | EUCTR2016-004427-24-AT (EUCTR) | 10/10/2017 | 30/05/2017 | An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study] | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Australia;Austria;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2016-004427-24-NL (EUCTR) | 06/09/2017 | 23/06/2017 | An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study] | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Austria;Australia;Israel;Germany;Netherlands;Italy;United Kingdom | ||
| 11 | EUCTR2016-004427-24-DE (EUCTR) | 24/08/2017 | 23/05/2017 | An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study] | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2016-004427-24-GB (EUCTR) | 21/07/2017 | 06/07/2017 | An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study] | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 13 | NCT03154333 (ClinicalTrials.gov) | June 1, 2017 | 10/5/2017 | Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex | Epidermolysis Bullosa Simplex | Drug: diacerein 1% ointment;Drug: A placebo ointment | Castle Creek Pharmaceuticals, LLC | NULL | Terminated | 4 Years | N/A | All | 54 | Phase 2 | United States;Australia;Austria;France;Germany;Israel;Netherlands;United Kingdom |
| 14 | EUCTR2013-002034-21-AT (EUCTR) | 16/12/2013 | 01/08/2013 | Diacerein for butterfly children | Diacerein for the treatment of Epidermolysis bullosa simplex - Diacerein for EBS | Epidermolysis bullosa simplex - type Dowling-Meara;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: SimpleCare INN or Proposed INN: DIACEREIN | EB House Austria | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Austria | |||
| 15 | EUCTR2018-000439-29-NL (EUCTR) | 27/09/2018 | A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB) | A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB) | Epidermolysis Bullosa (EB) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: CCP-020 INN or Proposed INN: DIACEREIN | Castle Creek Pharmaceuticals, LLC | NULL | NA | Female: yes Male: yes | 20 | Phase 1 | France;United States;Germany;Netherlands;United Kingdom | |||
| 16 | EUCTR2016-004427-24-FR (EUCTR) | 21/08/2017 | An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) | Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein | Castle Creek Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom |