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

  
30 trials found
No.TrialIDDate_
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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
19EUCTR2014-001644-38-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
20EUCTR2014-001645-24-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
21EUCTR2014-001645-24-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
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-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
30EUCTR2007-001014-17-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