Jorveza 1 mg orodispersible tablets ( 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3

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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PhaseCountries
1EUCTR2020-001314-37-PT
(EUCTR)
26/11/202112/02/2021Clinical 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 - Once daily versus twice daily budesonide orodispersible tablets for induction of remission in EoE 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 1 mg orodispersible tablets
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
2EUCTR2017-003516-39-ES
(EUCTR)
22/07/202114/06/2021A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remissionDouble-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission 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]
Trade Name: Jorveza 1 mg orodispersible tablets
Product Name: Budesonide 1 mg orodispersible tablets
Product Code: BUL 1 mg
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza 0.5 mg orodispersible tablets
Product Name: Budesonide 0.5 mg orodispersible tablets
Product Code: BUL 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3Spain;Germany;Switzerland;Italy
3EUCTR2017-003516-39-DE
(EUCTR)
28/04/202121/12/2020A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remissionDouble-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission 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]
Trade Name: Jorveza 1 mg orodispersible tablets
Product Name: Budesonide 1 mg orodispersible tablets
Product Code: BUL 1 mg
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza 0.5 mg orodispersible tablets
Product Name: Budesonide 0.5 mg orodispersible tablets
Product Code: BUL 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3Spain;Germany;Switzerland;Italy