Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Rifaximin-EIR

• Registration Number: NCT00528073
• Lead Sponsor: Alfasigma S.p.A.

Brief Summary

This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Primary Completion: 2009-03
• Study Completion: 2009-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-19
• Last Update Posted: 2010-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

• diagnosis of Crohn's disease localised in the ileum and/or colon, documented either radiologically or endoscopically at least 3 months previously;
• patients with a CDAI of ≥ 220 to ≤ 400;
• patients capable of and willing to conform to the study protocol;
• patients who have provided signed and dated written informed consent.

Exclusion Criteria

• patients potentially needing immediate surgery for Crohn's disease, including patients with occlusive symptoms and/or stenotic tract with dilation above;
• patients with active perianal Crohn's disease;
• patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement;
• patients with symptoms attributed to Short Bowel Syndrome or previous surgery;
• patients with stoma;
• patients affected by upper gastro-intestinal disease (gastro-duodenum-jejunum Crohn's disease) alone or in combination with colitis or ileitis;
• patients treated with: oral steroids and budesonide less than 30 days prior to screening; i.v. steroids less than 30 days prior to screening; antibiotics (such as metronidazole, tinidazole, ciprofloxacin, clarithromycin) less than 15 days prior to screening;
• rectal steroids less than 30 days prior to the screening visit;
• anti-tumour necrosis factor (anti-TNF) and other biological therapies less than 6 months prior to the screening visit;
• pregnant women or nursing mothers;
• females of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment;
• patients with severe hepatic insufficiency (Child C);
• patients with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 - 4);
• patients with known hypersensitivity to Rifaximin;
• any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological or neoplastic disease;
• withdrawal of informed consent;
• patients who have used any investigational drug (except biological therapies) within 3 months prior to screening;
• patients who have donated 250 ml or more of blood in the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Rifaximin-EIR	Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid
B	Rifaximin-EIR	Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid
C	Rifaximin-EIR	Rifaximin-EIR tablet 3x400 mg bid
D	Rifaximin-EIR	Placebo 3 tablets bid

Primary Outcome Measures

Name	Time	Method
Clinical remission (Crohn's Disease Activity Index < 150 points)	After 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Clinical response (reduction of baseline CDAI score by 100 points or more)	Any time during the 12 weeks of treament
Clinical response (reduction of baseline CDAI by 70 points or more)	At any time during the 12 weeks of treatment
Time to obtain clinical response and remission	During the 12 weeks of treatment
Maintenance of clinical remission	12 weeks after the end of the 12 weeks of treatment
Number of treatment failures	During the 12 weeks of treatment
Definition of therapeutic dose to be used in subsequent phase III trials.	After statistical analysis of the results
Adverse events	Throughout the study

Trial Locations

Locations (57)

CHU Amiens, Hôpital Nord; 🇫🇷 Amiens Cedex, France

Hôpital Saint André; 🇫🇷 Bordeaux Cedex, France

CHU Grenoble, Hôpital Michallon; 🇫🇷 Grenoble Cedex 9, France

CHU de Nice, Hôpital de l'Archet II; 🇫🇷 Nice Cedex 3, France

CHU de Rouen, Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Charité Campus Mitte; 🇩🇪 Berlin, Germany

Charité Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin; 🇩🇪 Frankfurt/Main, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Abteilung Gastroenterologie, Charité Campus Benjamin Franklin; 🇩🇪 Hindenburgdamm 30, Berlin, Germany

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