Entocort ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病7

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-003743-22-IT
(EUCTR)
01/12/201108/03/2012A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entocort
INN or Proposed INN: BUDESONIDE
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Canada;Germany;Italy
2NCT01453946
(ClinicalTrials.gov)
December 201114/10/2011Safety and Maintenance Study of Entocort for Children With Crohn's DiseaseA Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveCrohn's DiseaseDrug: EntocortPadagis LLCNULLCompleted5 Years17 YearsAll55Phase 3United States;Canada;Germany;Italy;Poland
3NCT01444092
(ClinicalTrials.gov)
November 201128/9/2011Safety Study of Entocort for Children With Crohn's DiseaseA Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveCrohn's DiseaseDrug: EntocortPadagis LLCNULLCompleted5 Years17 YearsAll123Phase 3United States;Canada;Germany;Italy;Poland
4EUCTR2008-001137-99-GB
(EUCTR)
28/04/200927/11/2008 CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Ciprofloxacin
Product Code: PL 20532/0012
INN or Proposed INN: Ciprofloxacin hydrochloride
Product Name: Budesonide
Product Code: PL 17901/0122
INN or Proposed INN: Budesonide
Other descriptive name: Entocort CR
Trade Name: DOXYCYCLINE
Product Name: DOXYCYCLINE
INN or Proposed INN: DOXYCYCLINE HYCLATE
Other descriptive name: DOXYCYCLINE
Trade Name: HYDROXYCHLOROQUINE
Product Name: HYDROXYCHLOROQUINE SULPHATE
INN or Proposed INN: HYDROXYCHLOROQUINE SULPHATE
Other descriptive name: PLAQUENIL
Royal Liverpool & Broadgreen University Hospitals TrustUniversity of LiverpoolNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
5EUCTR2011-003743-22-DE
(EUCTR)
20/10/2011A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: budesonide
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110United States;Canada;Poland;Germany;Italy
6EUCTR2011-003742-40-DE
(EUCTR)
20/10/2011A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: BUDESONIDE
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
50United States;Canada;Poland;Germany;Italy
7EUCTR2014-004132-20-Outside-EU/EEA
(EUCTR)
28/07/2016Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in JapanA multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Entocort
Product Code: D9421-C
INN or Proposed INN: budesonide
Trade Name: Pentasa
INN or Proposed INN: mesalazine
AstraZeneca K.K.NULLNAFemale: yes
Male: yes
112Phase 3Japan