Rifaximin ( DrugBank: Rifaximin )


8 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病5
65原発性免疫不全症候群2
93原発性胆汁性胆管炎1
96クローン病30
97潰瘍性大腸炎1
99慢性特発性偽性腸閉塞症2
296胆道閉鎖症1
299嚢胞性線維症1

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03575195
(ClinicalTrials.gov)
July 15, 201921/6/2018Microbiota Intervention to Change the Response of Parkinson's DiseaseMicrobiota Intervention to Change the Response of Parkinson's DiseaseParkinson DiseaseDrug: Rifaximin;Other: PlaceboUniversity of California, San FranciscoNova Southeastern University;Gateway Institute for Brain ResearchRecruiting30 YearsN/AAll86Phase 1/Phase 2United States
2NCT03958708
(ClinicalTrials.gov)
May 13, 201914/5/2019Modulation of Gut Microbiota by Rifaximin in PD PatientsModulation of Gut Microbiota by Rifaximin in PD PatientsParkinson Disease;InflammationDrug: Rifaximin 550 MGTaipei Medical University Shuang Ho HospitalNULLRecruiting45 Years70 YearsAll20Phase 1/Phase 2Taiwan
3NCT04730245
(ClinicalTrials.gov)
June 1, 201825/1/2021Microbiota Modification for the Treatment of Motor Complication of Parkinson´s DiseaseTargeting Gut Microbiota for Motor Complications in Parkinson´s DiseaseParkinson's Disease AggravatedDrug: sodium phosphate enema, oral rifaximin and polyethylene glycolTorre Médica SantéNULLCompleted18 YearsN/AAll14Phase 1Mexico
4NCT02470780
(ClinicalTrials.gov)
December 20154/6/2015Treating Bacterial Overgrowth in Parkinson's DiseaseTreating Bacterial Overgrowth in Parkinson's DiseaseParkinson's Disease;Small Intestinal Bacterial OvergrowthDrug: Rifaximin;Drug: PlaceboUniversity of CincinnatiNULLCompleted18 YearsN/AAll24Phase 2/Phase 3United States
5NCT01662791
(ClinicalTrials.gov)
September 20127/8/2012Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial OvergrowthWeight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial OvergrowthParkinson's DiseaseDrug: RifaximinMayo ClinicNULLCompleted18 YearsN/AAll49Phase 3United States

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01946906
(ClinicalTrials.gov)
October 201312/9/2013The Rifaximin Study in CVIDEffects of Rifaximin, by Modulation of the Gut Microbiota, on Markers of Systemic Inflammation in Patients With Common Variable Immunodeficiency - An Exploratory Open-label Randomized Controlled TrialCommon Variable Immunodeficiency (CVID)Drug: RifaximinOslo University HospitalNULLCompleted18 Years74 YearsBoth40Phase 4Norway
2EUCTR2013-000883-27-NO
(EUCTR)
16/08/201320/06/2013The effects of the local acting antibiotic Rifaximin on markers of inflammation in the blood by changing the bacterial composition in the gut, in patients with common variable immunodeficiency.EFFECTS OF RIFAXIMIN, BY MODULATION OF THE GUT MICROBIOTA, ON MARKERS OF SYSTEMIC INFLAMMATION IN PATIENTS WITH COMMON VARIABLE IMMUNODEFICIENCY - AN EXPLORATORY OPEN-LABEL RANDOMIZED CONTROLLED TRIAL Adult patients with the diagnosis of Common variable deficiency and fulfill the inclusion and exclusion criteria, will be invited to participate in the study.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: XifaxanOslo University hospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100046346
2021-06-012021-05-14A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis primary biliary cholangitisUrsodeoxycholic acid group:Ursodeoxycholic acid;Rifaximin group :UDCA and rifaximin;Xiangya Hospital of Central South UniversityNULLRecruiting1875BothUrsodeoxycholic acid group:30;Rifaximin group :30;N/AChina

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
1NCT04154735
(ClinicalTrials.gov)
November 20198/3/2019Autologous Transplant Targeted Against Crohn'sAutologous Hematopoietic Stem Cell Transplant for Crohn's DiseaseCrohn's DiseaseDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: TacrolimusNorthwestern UniversityNULLWithdrawn18 Years49 YearsAll0Phase 2United States
2NCT04254549
(ClinicalTrials.gov)
June 14, 20193/2/2020Rifaximin in Patients With Diabetic GastroparesisEvaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.Crohn Disease;Diabetic GastroparesisDrug: Rifaximin;Drug: PlaceboMayo ClinicNULLRecruiting18 Years75 YearsAll40Phase 2United States
3EUCTR2017-002258-36-NL
(EUCTR)
25/05/201817/10/2017Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA
ALFASIGMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2Spain;Belgium;Germany;Netherlands;Italy
4EUCTR2017-002258-36-BE
(EUCTR)
05/02/201802/10/2017Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA
ALFASIGMA S.P.A.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Belgium;Netherlands;Germany
5EUCTR2017-002258-36-ES
(EUCTR)
04/12/201703/10/2017Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA
ALFASIGMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2Spain;Germany
6EUCTR2017-002258-36-DE
(EUCTR)
21/11/201701/08/2017 Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA
ALFASIGMA S.P.A.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Belgium;Netherlands;Germany
7NCT03537157
(ClinicalTrials.gov)
November 16, 201715/5/2018A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence PreventionA Phase II, Multicentre, Double-blind, Randomised, Placebo-controlled Study of Rifaximin Delayed Release 400 mg Tablet: Clinical Efficacy and Safety in the Prevention of Post-operative Endoscopic Crohn's Disease RecurrenceCrohn DiseaseDrug: Rifaximin delayed release tablets;Other: PlaceboAlfasigma S.p.A.CromsourceTerminated18 Years75 YearsAll43Phase 2Italy
8NCT03185624
(ClinicalTrials.gov)
July 25, 201711/6/2017Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's DiseaseEffectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled TrialCrohn DiseaseDrug: RifaximinSixth Affiliated Hospital, Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw HospitalNot yet recruiting18 Years65 YearsAll80Phase 3China
9NCT03185611
(ClinicalTrials.gov)
May 18, 201711/6/2017Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's DiseaseEffectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled TrialCrohn DiseaseDrug: Rifaximin;Drug: AzathioprineSixth Affiliated Hospital, Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw HospitalRecruiting18 Years65 YearsAll120Phase 3China
10NCT02620007
(ClinicalTrials.gov)
December 201530/11/2015Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn DiseaseMulticenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn DiseaseCrohn Disease;Adherent-invasive E. ColiDrug: Ciprofloxacin;Drug: Rifaximin;Drug: Ciprofloxacin Placebo;Drug: Rifaximin PlaceboAssistance Publique - Hôpitaux de ParisNULLRecruiting18 Years80 YearsAll62Phase 2France
11EUCTR2014-001645-24-PL
(EUCTR)
29/05/201506/05/2015 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
12EUCTR2014-001644-38-PL
(EUCTR)
13/03/201530/12/2014 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
13EUCTR2014-001645-24-DE
(EUCTR)
09/02/201501/10/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
14EUCTR2014-001644-38-DE
(EUCTR)
02/02/201518/09/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
15EUCTR2014-001645-24-CZ
(EUCTR)
09/01/201530/09/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc subsidiary of Valeant Pharmaceuticals International IncNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
16EUCTR2014-001644-38-CZ
(EUCTR)
09/01/201519/09/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc. subsidiary of Valeant Pharmaceuticals International InNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
17NCT02272868
(ClinicalTrials.gov)
January 201516/10/2014Fecal Microbial Transplant in Pediatric Crohn's DiseaseFecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control StudyCrohn's DiseaseBiological: Fecal Microbial transplant;Drug: Normal Saline;Drug: rifaximin+omeprazole+miralaxSeattle Children's HospitalNULLTerminated12 Years21 YearsAll7Phase 1/Phase 2United States
18EUCTR2014-001644-38-FR
(EUCTR)
08/12/201422/06/2015A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
19EUCTR2014-001645-24-FR
(EUCTR)
18/11/201422/06/2015A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
20EUCTR2014-001644-38-HU
(EUCTR)
18/11/201417/09/2014 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany
21EUCTR2014-001645-24-HU
(EUCTR)
18/11/201424/09/2014 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany
22NCT02240108
(ClinicalTrials.gov)
October 28, 201411/9/2014One Year Study of Rifaximin Delayed Release (DR) in Crohn's DiseaseA Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's DiseaseCrohn's DiseaseDrug: Rifaximin EIR;Drug: PlaceboBausch Health Americas, Inc.Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLCTerminated18 YearsN/AAll81Phase 3United States
23NCT02240121
(ClinicalTrials.gov)
August 21, 201411/9/2014One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's DiseaseA Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's DiseaseCrohn's DiseaseDrug: Rifaximin EIR;Drug: PlaceboBausch Health Americas, Inc.Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLCTerminated18 YearsN/AAll80Phase 3United States
24EUCTR2011-002821-24-IT
(EUCTR)
21/07/201127/02/2012Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011 Treatment of active, moderate 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]
Product Name: Rifaximin-EIR
Product Code: NA
INN or Proposed INN: RIFAXIMIN
Other descriptive name: NA
ALFA WASSERMANNNULLNot RecruitingFemale: yes
Male: yes
Italy
25NCT00603616
(ClinicalTrials.gov)
November 200816/1/2008Induction of Clinical Response Using Rifaximin in Crohn's DiseaseA Randomized, Prospective, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of Rifaximin for the Treatment of Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: Placebo Comparator;Drug: RifaximinScott LeeBausch Health Americas, Inc.Completed18 Years80 YearsAll36Phase 2United States
26EUCTR2007-001014-17-DE
(EUCTR)
07/01/200803/03/2008A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s diseaseA Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Rifaximin-EIRAlfa Wassermann S.p.A.NULLNot RecruitingFemale: yes
Male: yes
424Phase 2France;Hungary;Germany;Italy
27EUCTR2007-001014-17-HU
(EUCTR)
16/10/200719/06/2007A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Rifaximin-EIR
INN or Proposed INN: Rifaximin
Alfa Wassermann S.p.A.NULLNot RecruitingFemale: yes
Male: yes
424Phase 2France;Hungary;Germany;Italy
28NCT00528073
(ClinicalTrials.gov)
September 200710/9/2007Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's DiseaseA Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's DiseaseCrohn's DiseaseDrug: Rifaximin-EIRAlfa Wassermann S.p.A.NULLCompleted18 Years75 YearsBoth410Phase 2France;Germany;Hungary;Israel;Italy;Poland;Russian Federation
29EUCTR2007-001014-17-FR
(EUCTR)
26/07/200701/06/2007A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s diseaseA Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Rifaximin-EIRAlfa Wassermann S.p.A.NULLNot RecruitingFemale: yes
Male: yes
424Phase 2France;Hungary;Germany;Italy
30EUCTR2007-001014-17-IT
(EUCTR)
26/07/200724/10/2007A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06 moderate active Crohn disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: NORMIX*AD 12CPR RIV 200MG
INN or Proposed INN: Rifaximin
ALFA WASSERMANNNULLNot RecruitingFemale: yes
Male: yes
424Phase 2Hungary;Germany;France;Italy

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00355602
(ClinicalTrials.gov)
July 200621/7/2006Antibiotics for the Treatment of Ulcerative ColitisUse of Antibiotics to Eradicate Bacterial Pathogens Colonising the Colonic Mucosa in Ulcerative Colitis PatientsColitis, UlcerativeDrug: Cefuroxime;Drug: Ciprofloxacin;Drug: Clarithromycin;Drug: Cotrimoxazole;Drug: Coamoxiclav;Drug: metronidazole;Drug: neomycin;Drug: rifaximin;Drug: Vancomycin;Drug: DoxycyclineUniversity of DundeeTenovus ScotlandCompleted18 Years79 YearsBoth40N/AUnited Kingdom

99. 慢性特発性偽性腸閉塞症


臨床試験数 : 4 薬物数 : 9 - (DrugBank : 2) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 4
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04118699
(ClinicalTrials.gov)
December 25, 201923/9/2019Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 TrialEfficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Single Center, Randomized, Placebo Controlled, Double-blind Phase 2 TrialChronic Intestinal Pseudo-obstructionDrug: Rifaximin oral tablet;Drug: Placebo oral tabletYokohama City UniversityASKA Pharmaceutical Co., Ltd.Active, not recruiting20 Years74 YearsAll12Phase 2Japan
2JPRN-jRCT2031190137
25/12/201920/11/2019Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 TrialEfficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial Chronic Intestinal Pseudo-obstruction
CIPO, abdominal bloating
Two tablets of the investigational product per dosing (400 mg of rifaximin) or the placebo are orally administered 3 times daily for 4 weeks.Ohkubo HidenoriNULLNot Recruiting>= 20age old< 75age oldBoth12Phase 2Japan

296. 胆道閉鎖症


臨床試験数 : 71 薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1900023843
2019-07-012019-06-14Effects of intestinal flora distribution and mucosal structure on pediatric liver transplantation with biliary atresiaEffects of intestinal flora distribution and mucosal structure on pediatric liver transplantation with biliary atresia Biliary Atresia1:No;2:probiotics;3:Rifaximin;Tianjin First Center HospitalNULLPending018Both1:20;2:10;3:10;China

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05408910
(ClinicalTrials.gov)
July 20232/6/2022Rifaximin for Treatment of Bloating in Children and Adults With Cystic FibrosisRifaximin for Treatment of Bloating in Children and Adults With Cystic FibrosisCystic Fibrosis;Abdominal Pain;Small Bowel DiseaseDrug: Rifaximin 550 MG Oral Tablet [XIFAXAN];Drug: PlaceboWake Forest University Health SciencesEmory University;University of Minnesota;University of Texas Southwestern Medical CenterNot yet recruiting12 YearsN/AAll100Phase 2/Phase 3United States