Episalvan gel ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
36表皮水疱症12

36. 表皮水疱症


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
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gender
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PhaseCountries
1EUCTR2016-002066-32-DK
(EUCTR)
05/04/201817/01/2018A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany
2EUCTR2016-002066-32-BE
(EUCTR)
23/03/201817/01/2018A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNot RecruitingFemale: yes
Male: yes
192Phase 3Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany
3EUCTR2016-002066-32-HR
(EUCTR)
26/02/201812/04/2018A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany
4EUCTR2016-002066-32-HU
(EUCTR)
08/01/201829/11/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNot RecruitingFemale: yes
Male: yes
164Phase 3Hong Kong;Greece;Spain;Ireland;Austria;Israel;Chile;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Denmark;Australia;Germany
5EUCTR2016-002066-32-IE
(EUCTR)
22/12/201707/03/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;Greece;Spain;Ukraine;Ireland;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany
6EUCTR2016-002066-32-GB
(EUCTR)
10/11/201713/02/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Greece;Spain;Ukraine;Ireland;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany
7EUCTR2016-002066-32-IT
(EUCTR)
18/10/201730/01/2018A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
164 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany
8EUCTR2016-002066-32-GR
(EUCTR)
16/10/201705/05/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle (placebo) gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany
9EUCTR2016-002066-32-AT
(EUCTR)
26/09/201708/03/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany
10EUCTR2016-002066-32-ES
(EUCTR)
16/03/201710/03/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
MedDRA version: 19.1;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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Greece;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Croatia;Australia;Germany
11EUCTR2016-002066-32-CZ
(EUCTR)
29/11/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Georgia;Germany
12EUCTR2016-002066-32-DE
(EUCTR)
09/03/2017A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB)Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study Inherited Epidermolysis Bullosa
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]
Trade Name: Episalvan gel
Product Name: Oleogel-S10
INN or Proposed INN: Birch bark extract
Other descriptive name: BIRCH BARK EXTRACT
Amryt Research LimitedNULLNAFemale: yes
Male: yes
192Phase 3Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany