96. Crohn disease Clinical trials / Disease details


Clinical trials : 2,400 Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002258-36-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
2EUCTR2017-002258-36-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
3EUCTR2017-002258-36-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
4EUCTR2017-002258-36-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
5EUCTR2011-002821-24-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
6EUCTR2007-001014-17-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
7EUCTR2007-001014-17-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
8NCT00528073
(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
9EUCTR2007-001014-17-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