96. クローン病
[臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
26 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04233463
(ClinicalTrials.gov)
January 202015/1/2020The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's DiseaseThe Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized StudyCrohn DiseaseDietary Supplement: Modulen;Drug: BudesonideHillel Yaffe Medical CenterNULLNot yet recruiting18 Years70 YearsAll50N/AIsrael
2JPRN-jRCT1051190043
20/12/201802/09/2019Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 Crohn's diseaseAt the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Takehara TetsuoIijima HidekiRecruiting20ageNot applicableBoth15Phase 2Japan
3JPRN-UMIN000031839
2018/04/0101/04/2018Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients Crohn's diseaseAt the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Osaka University Graduate School of MedicineDepartment of Gastroenterology and HepatologyJapan Community Health care Organizationi Osaka Hospital, Gastroenterology and HepatologyNational Hospital Organization Osaka National Hospital, Gastroenterology and HepatologyOsaka Rosai Hospital , Gastroenterology and HepatologyKansai Rosai Hospital, Gastroenterology and HepatologyItami City Hospital, Gastroenterology and HepatologyHyogo Prefectural Nishinomiya Hospital, Gastroenterology and HepatologyNishinomiya Municipal central hospital, Gastroenterology and HepatologyRecruiting20years-oldNot applicableMale and Female15Not selectedJapan
4JPRN-jRCTs021200013
28/02/201831/07/2020A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST Crohn's disease
Crohn's disease;D003424
Ustekinumab monotherapy for 32 weeks.Moroi RintaoNULLRecruiting>= 18age old<= 75age oldBoth80Phase 3Japan
5JPRN-UMIN000030884
2018/02/2720/02/2018A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. Crohn's diseaseUstekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.
Tohoku University Hospital, Division of GastroenterologyNULLRecruiting18years-old75years-oldMale and Female80Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-JapicCTI-184152
01/9/201711/10/2018Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's diseaseInvestigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease Crohn's diseaseIntervention name : Budesonide ( Zentacort Capsules 3mg )
INN of the intervention : Budesonide
Dosage And administration of the intervention : Oral
ZERIA Pharmaceutical Co., Ltd.NULLrecruitingBOTH200NANULL
7NCT01783106
(ClinicalTrials.gov)
February 1, 201431/1/2013Antibiotics and Hydroxychloroquine in Crohn'sA Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's DiseaseCrohn's DiseaseDrug: Ciprofloxacin;Drug: Doxycycline;Drug: Hydroxychloroquine;Drug: BudesonideRoyal Liverpool University HospitalNational Association for Colitis and Crohn's Disease;National Institute for Health Research, United KingdomCompleted18 YearsN/AAll59Phase 2United Kingdom
8EUCTR2011-003743-22-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, 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
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
ASTRAZENECANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United States;Canada;Germany;Italy
9EUCTR2008-006957-42-BG
(EUCTR)
17/11/200921/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania
10NCT01086553
(ClinicalTrials.gov)
November 200912/3/20109 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's DiseaseDouble-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's DiseaseCrohn´s DiseaseDrug: budesonideDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth471Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-006957-42-DE
(EUCTR)
30/10/200930/07/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany
12EUCTR2008-006957-42-LT
(EUCTR)
19/10/200912/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania
13EUCTR2008-006957-42-SK
(EUCTR)
14/10/200919/10/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany
14EUCTR2008-006957-42-LV
(EUCTR)
25/09/200908/09/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia
15EUCTR2008-006957-42-CZ
(EUCTR)
24/09/200907/09/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2008-006957-42-HU
(EUCTR)
16/09/200904/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania
17EUCTR2007-005455-42-NL
(EUCTR)
26/02/200918/09/2008ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIALENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIAL Crohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction.
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Budenofalk
Product Name: Budenofalk
INN or Proposed INN: BUDESONIDE
Trade Name: Kenacort
Product Name: Kenacort
INN or Proposed INN: TRIAMCINOLONE
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
42Netherlands
18EUCTR2004-001213-34-GB
(EUCTR)
30/01/200719/08/2008Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicyl acid
Trade Name: Budenofalk
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Czech Republic;United Kingdom
19EUCTR2004-001213-34-SK
(EUCTR)
16/12/200416/08/2005Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Phase 3Czech Republic;Slovakia;United Kingdom
20EUCTR2004-001213-34-CZ
(EUCTR)
02/11/200402/11/2004Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370United Kingdom;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00300118
(ClinicalTrials.gov)
September 20047/3/2006Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease PatientsCrohn's DiseaseDrug: budesonide;Drug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth311Phase 3Germany
22NCT00554710
(ClinicalTrials.gov)
May 20016/11/2007Top Down Versus Step Up Strategies in Crohn's DiseaseThe Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the BeneluxCrohn's DiseaseDrug: infliximab+azathioprine;Drug: methylprednisolone or budesonideBelgian IBD Research GroupCentocor BV;Schering-PloughCompleted16 Years75 YearsBoth129Phase 4Belgium
23JPRN-JapicCTI-080566
09/04/2008A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's DiseaseA Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease Crohn's DiseaseIntervention name : Budesonide
Dosage And administration of the intervention : Oral
AstraZenecaNULL1865BOTHPhase 2NULL
24EUCTR2014-004132-20-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
25EUCTR2011-003743-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-003742-40-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