High dose
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 97 | 潰瘍性大腸炎 | 12 |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
Showing 1 to 10 of 12 trials
| 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 | NCT04314375 (ClinicalTrials.gov) | March 202320230300 | 17/3/202020200317 | Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets ... | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, ... | Ulcerative Colitis | Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Not yet recruiting | 5 Years | 17 Years | All | 70 | Phase 4 | NULL |
| 2 | NCT05587673 (ClinicalTrials.gov) | October 6, 202220221006 | 14/10/202220221014 | High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD) | A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease. A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administrati ... | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Indeterminate Colitis | Drug: Methylprednisolone | Stanford University | NULL | Recruiting | 4 Years | 25 Years | All | 30 | Phase 1 | United States |
| 3 | JPRN-jRCT2021220013 (jRCT2021220013) | 01/07/202220220701 | 18/06/202220220618 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Acti ... | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacok ... | Ulcerative Colitis (UC) | Ozanimod High Dose Ozanimod Low Dose | Liu W. Jerry | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 2-3 | France;United States;Japan |
| 4 | JPRN-jRCT2071210030 (jRCT2071210030) | 19/10/202120211019 | 31/05/202120210531 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intrave ... | Colitis, Ulcerative | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm. Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infus ... | Shikamura Mitsuhiro | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania ... |
| 5 | NCT04857112 (ClinicalTrials.gov) | September 29, 202120210929 | 19/4/202120210419 | Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis | A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC) A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Effic ... | Ulcerative Colitis | Drug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 336 | Phase 2 | United States |
| 6 | NCT02493712 (ClinicalTrials.gov) | January 201620160100 | 7/7/201520150707 | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98 ... | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98 ... | Colitis, Ulcerative | Drug: High dose;Drug: Low dose;Drug: Placebo | Holy Stone Healthcare Co., Ltd | inVentiv Health Clinical | Completed | 18 Years | 75 Years | All | 51 | Phase 2 | Italy;Taiwan |
| 7 | NCT02093663 (ClinicalTrials.gov) | December 12, 201420141212 | 17/3/201420140317 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerat ... | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX M ... | Ulcerative Colitis | Drug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose) | Shire | NULL | Completed | 5 Years | 17 Years | All | 107 | Phase 3 | United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands |
| 8 | NCT01959165 (ClinicalTrials.gov) | November 21, 201320131121 | 8/10/201320131008 | MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients | Ulcerative Colitis | Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo | AstraZeneca | NULL | Completed | 18 Years | 65 Years | All | 44 | Phase 2 | Japan | |
| 9 | NCT01240915 (ClinicalTrials.gov) | February 201120110200 | 10/11/201020101110 | A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Mod ... | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Invest ... | Colitis, Ulcerative | Drug: placebo;Drug: MultiStem low dose;Drug: MultiStem high dose | Pfizer | Athersys, Inc | Completed | 18 Years | N/A | All | 105 | Phase 2 | United States;Belgium;Canada;Germany;Hungary;Italy;Slovakia;Sweden |
| 10 | EUCTR2006-005299-42-BE (EUCTR) | 20/05/200820080520 | 07/03/200820080307 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refract ... | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refract ... | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesio ... | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive ... | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain |