Budesonide 1 mg orodispersible tablets (BUL 1 mg) ( DrugBank: Budesonide )


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2

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_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2020-001314-37-AT
(EUCTR)
06/05/202101/03/2021clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagusDouble-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg)
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza
Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
242Phase 3Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland
2EUCTR2020-001314-37-DE
(EUCTR)
26/04/202127/11/2020clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagusDouble-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg)
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza
Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
242Phase 3Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland