96. クローン病 Crohn disease Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04233463 (ClinicalTrials.gov) | January 2020 | 15/1/2020 | The 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 | The 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 Study | Crohn Disease | Dietary Supplement: Modulen;Drug: Budesonide | Hillel Yaffe Medical Center | NULL | Not yet recruiting | 18 Years | 70 Years | All | 50 | N/A | Israel |
| 2 | JPRN-jRCT1051190043 | 20/12/2018 | 02/09/2019 | Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis | Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 | Crohn's disease | At 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 Tetsuo | Iijima Hideki | Recruiting | 20age | Not applicable | Both | 15 | Phase 2 | Japan |
| 3 | JPRN-UMIN000031839 | 2018/04/01 | 01/04/2018 | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis | Safety 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 disease | At 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 Hepatology | Japan 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 Hepatology | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not selected | Japan |
| 4 | JPRN-jRCTs021200013 | 28/02/2018 | 31/07/2020 | A 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 Rintao | NULL | Recruiting | >= 18age old | <= 75age old | Both | 80 | Phase 3 | Japan |
| 5 | JPRN-UMIN000030884 | 2018/02/27 | 20/02/2018 | 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. | 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. - A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease. (BUUST study) | Crohn's disease | Ustekinumab monotherapy for 32 weeks. Combination of Budesonide and Ustekinumab for 32 weeks. | Tohoku University Hospital, Division of Gastroenterology | NULL | Recruiting | 18years-old | 75years-old | Male and Female | 80 | Phase 3 | Japan |
| 6 | JPRN-JapicCTI-184152 | 01/9/2017 | 11/10/2018 | Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease | Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease | Crohn's disease | Intervention name : Budesonide ( Zentacort Capsules 3mg ) INN of the intervention : Budesonide Dosage And administration of the intervention : Oral | ZERIA Pharmaceutical Co., Ltd. | NULL | recruiting | BOTH | 200 | NA | NULL | ||
| 7 | NCT01783106 (ClinicalTrials.gov) | February 1, 2014 | 31/1/2013 | Antibiotics and Hydroxychloroquine in Crohn's | A Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's Disease | Crohn's Disease | Drug: Ciprofloxacin;Drug: Doxycycline;Drug: Hydroxychloroquine;Drug: Budesonide | Royal Liverpool University Hospital | National Association for Colitis and Crohn's Disease;National Institute for Health Research, United Kingdom | Completed | 18 Years | N/A | All | 59 | Phase 2 | United Kingdom |
| 8 | EUCTR2011-003743-22-IT (EUCTR) | 01/12/2011 | 08/03/2012 | 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 | 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 | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Canada;Germany;Italy | ||
| 9 | EUCTR2008-006957-42-BG (EUCTR) | 17/11/2009 | 21/08/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania | ||
| 10 | NCT01086553 (ClinicalTrials.gov) | November 2009 | 12/3/2010 | 9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease | Double-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 | Crohn´s Disease | Drug: budesonide | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 471 | Phase 3 | Germany |
| 11 | EUCTR2008-006957-42-DE (EUCTR) | 30/10/2009 | 30/07/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany | ||
| 12 | EUCTR2008-006957-42-LT (EUCTR) | 19/10/2009 | 12/08/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania | ||
| 13 | EUCTR2008-006957-42-SK (EUCTR) | 14/10/2009 | 19/10/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany | ||
| 14 | EUCTR2008-006957-42-LV (EUCTR) | 25/09/2009 | 08/09/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia | ||
| 15 | EUCTR2008-006957-42-CZ (EUCTR) | 24/09/2009 | 07/09/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania | ||
| 16 | EUCTR2008-006957-42-HU (EUCTR) | 16/09/2009 | 04/08/2009 | Double-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 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania | ||
| 17 | EUCTR2008-001137-99-GB (EUCTR) | 28/04/2009 | 27/11/2008 | 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 Trust | University of Liverpool | Not 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): no | United Kingdom | ||
| 18 | EUCTR2007-005455-42-NL (EUCTR) | 26/02/2009 | 18/09/2008 | ENDO 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 | ENDO 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 Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 42 | Netherlands | |||
| 19 | EUCTR2004-001213-34-GB (EUCTR) | 30/01/2007 | 19/08/2008 | 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 patients - Oral budesonide vs. oral mesalazine in active 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Czech Republic;United Kingdom | |||
| 20 | EUCTR2004-001213-34-SK (EUCTR) | 16/12/2004 | 16/08/2005 | 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 patients - Oral budesonide vs. oral mesalazine in active 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 3 | Czech Republic;Slovakia;United Kingdom | ||
| 21 | EUCTR2004-001213-34-CZ (EUCTR) | 02/11/2004 | 02/11/2004 | 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 patients - Oral budesonide vs. oral mesalazine in active 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | United Kingdom;Czech Republic | |||
| 22 | NCT00300118 (ClinicalTrials.gov) | September 2004 | 7/3/2006 | Oral 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 Patients | Crohn's Disease | Drug: budesonide;Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | Both | 311 | Phase 3 | Germany |
| 23 | NCT00554710 (ClinicalTrials.gov) | May 2001 | 6/11/2007 | Top Down Versus Step Up Strategies in Crohn's Disease | The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux | Crohn's Disease | Drug: infliximab+azathioprine;Drug: methylprednisolone or budesonide | Belgian IBD Research Group | Centocor BV;Schering-Plough | Completed | 16 Years | 75 Years | Both | 129 | Phase 4 | Belgium |
| 24 | EUCTR2014-004132-20-Outside-EU/EEA (EUCTR) | 28/07/2016 | Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japan | A 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. | NULL | NA | Female: yes Male: yes | 112 | Phase 3 | Japan | |||
| 25 | EUCTR2011-003743-22-DE (EUCTR) | 20/10/2011 | 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 | 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;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 AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | United States;Canada;Poland;Germany;Italy | ||||
| 26 | JPRN-JapicCTI-080566 | 09/04/2008 | A 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 | A 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 Disease | Intervention name : Budesonide Dosage And administration of the intervention : Oral | AstraZeneca | NULL | 18 | 65 | BOTH | Phase 2 | NULL | |||
| 27 | EUCTR2011-003742-40-DE (EUCTR) | 20/10/2011 | A 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 | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 50 | United States;Canada;Poland;Germany;Italy |