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

Sponsor:	Alfa Wassermann S.p.A.
Information provided by:	Alfa Wassermann S.p.A.
ClinicalTrials.gov Identifier:	NCT00528073

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: Rifaximin-EIR	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 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 Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Rifaximin

U.S. FDA Resources

Further study details as provided by Alfa Wassermann S.p.A.:

Primary Outcome Measures:

Clinical remission (Crohn's Disease Activity Index < 150 points) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response (reduction of baseline CDAI score by 100 points or more) [ Time Frame: Any time during the 12 weeks of treament ] [ Designated as safety issue: No ]
Clinical response (reduction of baseline CDAI by 70 points or more) [ Time Frame: At any time during the 12 weeks of treatment ] [ Designated as safety issue: No ]
Time to obtain clinical response and remission [ Time Frame: During the 12 weeks of treatment ] [ Designated as safety issue: No ]
Maintenance of clinical remission [ Time Frame: 2 weeks after the end of the 12 weeks of treatment ] [ Designated as safety issue: No ]
Maintenance of clinical remission [ Time Frame: 12 weeks after the end of the 12 weeks of treatment ] [ Designated as safety issue: No ]
Number of treatment failures [ Time Frame: During the 12 weeks of treatment ] [ Designated as safety issue: No ]
Definition of therapeutic dose to be used in subsequent phase III trials. [ Time Frame: After statistical analysis of the results ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment:	410
Study Start Date:	September 2007
Study Completion Date:	October 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid	Drug: Rifaximin-EIR Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease Other Name: GRACE
Experimental: B Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid	Drug: Rifaximin-EIR Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease Other Name: GRACE
Experimental: C Rifaximin-EIR tablet 3x400 mg bid	Drug: Rifaximin-EIR Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease Other Name: GRACE
Placebo Comparator: D Placebo 3 tablets bid	Drug: Rifaximin-EIR Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease Other Name: GRACE

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528073

Show 57 Study Locations

Sponsors and Collaborators

Alfa Wassermann S.p.A.

Investigators

Study Chair:	Pier Alessandro Monici Preti, MD	Alfa Wassermann
Study Director:	Maria Grimaldi, MD	Alfa Wassermann
Principal Investigator:	Cosimo Prantera, MD	S. Camillo - Forlanini Hospital

More Information

Publications:

Prantera C, Lochs H, Campieri M, Scribano ML, Sturniolo GC, Castiglione F, Cottone M. Antibiotic treatment of Crohn's disease: results of a multicentre, double blind, randomized, placebo-controlled trial with rifaximin. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1117-25.

Responsible Party:	Dr Pier Alessandro Monici Preti MD, Alfa Wassermann S.p.A.
ClinicalTrials.gov Identifier:	NCT00528073 History of Changes
Other Study ID Numbers:	RETIC/03/06, EudraCT: 2007-001014-17
Study First Received:	September 10, 2007
Last Updated:	February 19, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Alfa Wassermann S.p.A.:

Rifaximin-EIR
Crohn's disease
remission

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012