Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 410
- 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.
- 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)
Bnai Zion Medical Center
🇮🇱Haifa, Israel
CHU Amiens, Hôpital Nord
🇫🇷Amiens Cedex, France
CHU Grenoble, Hôpital Michallon
🇫🇷Grenoble Cedex 9, France
CHU de Nice, Hôpital de l'Archet II
🇫🇷Nice Cedex 3, France
Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin
🇩🇪Frankfurt/Main, Germany
Abteilung Gastroenterologie, Charité Campus Benjamin Franklin
🇩🇪Hindenburgdamm 30, Berlin, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika
🇭🇺Debrecen, Hungary
Charité Campus Mitte
🇩🇪Berlin, Germany
Gastroenterological Group Practice
🇩🇪Minden, Germany
Rabin Medical Center
🇮🇱Petah Tiqwa, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
The Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Azienda Ospedaliera Padova
🇮🇹Padova, Italy
Azienda Ospedaliera Universitaria Policlinico di Torvergata
🇮🇹Rome, Italy
Policlinico "A,. Gemelli"
🇮🇹Rome, Italy
Ospedale Mauriziano "Umberto I"
🇮🇹Turin, Italy
10 Wojskowy Szpital Kliniczny z Polikliniką
🇵🇱Bydgoszcz, Poland
Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny
🇵🇱Częstochowa, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱Warszawa, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji
🇵🇱Warszawa, Poland
Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky
🇷🇺Moscow, Russian Federation
Sokolov Clinical Hospital #122
🇷🇺St. Petersburg, Russian Federation
St. Petersburg Mechnikov State Medical Academy
🇷🇺St. Petersburg, Russian Federation
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika
🇭🇺Szeged, Hungary
Istituto Clinico Humanitas
🇮🇹Rozzano, Milan, Italy
Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Hôpital Saint André
🇫🇷Bordeaux Cedex, France
CHU de Rouen, Hôpital Charles Nicolle
🇫🇷Rouen, France
Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat
🇭🇺Gyula, Hungary
Jávorszky Ödön Kórház, Gasztroenterológiai Osztály
🇭🇺Vác, Hungary
Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat
🇭🇺Szekszárd, Hungary
Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza
🇭🇺Budapest, Hungary
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Casa Sollievo della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Foggia, Italy
A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74
🇮🇹Milan, Italy
Azienda Ospedaliera "San Camillo-Forlanini"
🇮🇹Rome, Italy
Azienda Ospedaliera S. Giovanni Battista Molinette
🇮🇹Turin, Italy
Szpital Specjalistyczny Św. Wojciecha- Adalberta
🇵🇱Gdańsk, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej
🇵🇱Katowice, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
🇵🇱Wroclaw, Poland
Sechenov Moscow Medical Academy
🇷🇺Moscow, Russian Federation
Rostov State Medical University City Hospital # 20
🇷🇺Rostov-na-Donu, Russian Federation
Russian Center of Functional Surgical Gastroenterology
🇷🇺Krasnodar, Russian Federation
State Scientific Centre of Coloproctology
🇷🇺Moscow, Russian Federation
City Clinical Hospital # 24
🇷🇺Moscow, Russian Federation
Nizhny Novgorod Regional Clinical Hospital
🇷🇺Nizhny Novgorod, Russian Federation
Novosibirsk State Medical University City Hospital #7
🇷🇺Novosibirsk, Russian Federation
City Polyclinic # 38
🇷🇺St. Petersburg, Russian Federation
Military Medical Academy
🇷🇺St. Petersburg, Russian Federation
MAPO, City Hospital # 26
🇷🇺St. Petersburg, Russian Federation
St. Petersburg MAPO, City Hospital #31
🇷🇺St. Petersburg, Russian Federation
Yaroslavl Regional Clinical Hospital
🇷🇺Yaroslavl, Russian Federation