BUET 0.5 mg ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
98好酸球性消化管疾患7

98. 好酸球性消化管疾患


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001485-99-DK
(EUCTR)
27/10/201706/07/2017Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;United Kingdom;Switzerland
2EUCTR2014-001485-99-IT
(EUCTR)
29/09/201720/01/2021Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo formaintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinicopathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Compressa effervescente 1 mg di budesonide per uso orodispersibile
Product Code: BUET 1 mg
INN or Proposed INN: BUDESONIDE
Product Name: Compressa effervescente 0,5 mg di budesonide per uso orodispersibile
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
DR. FALK PHARMA GMBHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Eswatini;Spain
3EUCTR2014-001485-99-NL
(EUCTR)
24/08/201602/05/2016Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland
4EUCTR2014-001485-99-ES
(EUCTR)
22/01/201617/11/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 18.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland
5EUCTR2014-001485-99-BE
(EUCTR)
22/01/201623/07/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland
6EUCTR2014-001485-99-GB
(EUCTR)
23/12/201523/10/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Belgium;Spain;Denmark;Netherlands;Germany;Switzerland;United Kingdom
7EUCTR2014-001485-99-DE
(EUCTR)
08/12/201529/06/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland