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

NCT ID: NCT00528073

Last Updated: 2010-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-10-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid

Group Type: EXPERIMENTAL

Rifaximin-EIR

Intervention Type: DRUG

Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease

B

Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid

Group Type: EXPERIMENTAL

Rifaximin-EIR

Intervention Type: DRUG

Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease

C

Rifaximin-EIR tablet 3x400 mg bid

Group Type: EXPERIMENTAL

Rifaximin-EIR

Intervention Type: DRUG

Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease

D

Placebo 3 tablets bid

Group Type: PLACEBO_COMPARATOR

Rifaximin-EIR

Intervention Type: DRUG

Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease

Interventions

Rifaximin-EIR

Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease

Intervention Type: DRUG

Other Intervention Names

GRACE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alfasigma S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Alfa Wassermann S.p.A.

Principal Investigators

Pier Alessandro Monici Preti, MD

Role: STUDY_CHAIR

Alfa Wassermann

Maria Grimaldi, MD

Role: STUDY_DIRECTOR

Alfa Wassermann

Cosimo Prantera, MD

Role: PRINCIPAL_INVESTIGATOR

S. Camillo - Forlanini Hospital

Locations

CHU Amiens, Hôpital Nord

Amiens, , France

Hôpital Saint André

Bordeaux, , France

CHU Grenoble, Hôpital Michallon

Grenoble, , France

CHU de Nice, Hôpital de l'Archet II

Nice, , 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 am Main, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Abteilung Gastroenterologie, Charité Campus Benjamin Franklin

Hindenburgdamm 30, Berlin, , Germany

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Gastroenterological Group Practice

Minden, , Germany

Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza

Budapest, , Hungary

Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika

Debrecen, , Hungary

Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat

Gyula, , Hungary

Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika

Szeged, , Hungary

Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat

Szekszárd, , Hungary

Jávorszky Ödön Kórház, Gasztroenterológiai Osztály

Vác, , Hungary

Bnai Zion Medical Center

Haifa, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, Foggia, Italy

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, , Italy

A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74

Milan, , Italy

Azienda Ospedaliera Padova

Padua, , Italy

Azienda Ospedaliera Universitaria Policlinico di Torvergata

Rome, , Italy

Azienda Ospedaliera "San Camillo-Forlanini"

Rome, , Italy

Policlinico "A,. Gemelli"

Rome, , Italy

Azienda Ospedaliera S. Giovanni Battista Molinette

Turin, , Italy

Ospedale Mauriziano "Umberto I"

Turin, , Italy

10 Wojskowy Szpital Kliniczny z Polikliniką

Bydgoszcz, , Poland

Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny

Częstochowa, , Poland

Szpital Specjalistyczny Św. Wojciecha- Adalberta

Gdansk, , Poland

Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej

Katowice, , Poland

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, , Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji

Warsaw, , Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

Wroclaw, , Poland

Russian Center of Functional Surgical Gastroenterology

Krasnodar, , Russia

Sechenov Moscow Medical Academy

Moscow, , Russia

State Scientific Centre of Coloproctology

Moscow, , Russia

City Clinical Hospital # 24

Moscow, , Russia

Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky

Moscow, , Russia

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, , Russia

Novosibirsk State Medical University City Hospital #7

Novosibirsk, , Russia

Rostov State Medical University City Hospital # 20

Rostov-on-Don, , Russia

City Polyclinic # 38

Saint Petersburg, , Russia

Military Medical Academy

Saint Petersburg, , Russia

Sokolov Clinical Hospital #122

Saint Petersburg, , Russia

St. Petersburg Mechnikov State Medical Academy

Saint Petersburg, , Russia

MAPO, City Hospital # 26

Saint Petersburg, , Russia

St. Petersburg MAPO, City Hospital #31

Saint Petersburg, , Russia

Yaroslavl Regional Clinical Hospital

Yaroslavl, , Russia

Countries

France; Germany; Hungary; Israel; Italy; Poland; Russia

References

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. doi: 10.1111/j.1365-2036.2006.02879.x.

Reference Type: BACKGROUND

PMID: 16611272 (View on PubMed)

Prantera C, Lochs H, Grimaldi M, Danese S, Scribano ML, Gionchetti P; Retic Study Group (Rifaximin-Eir Treatment in Crohn's Disease). Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease. Gastroenterology. 2012 Mar;142(3):473-481.e4. doi: 10.1053/j.gastro.2011.11.032. Epub 2011 Dec 6.

Reference Type: DERIVED

PMID: 22155172 (View on PubMed)

Other Identifiers

EudraCT: 2007-001014-17

Identifier Type: -

Identifier Source: secondary_id

RETIC/03/06

Identifier Type: -

Identifier Source: org_study_id