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

Condition(s) targeted: Crohn's Disease

Intervention: Rifaximin-EIR (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Alfa Wassermann S.p.A.

Official(s) and/or principal investigator(s):
Pier Alessandro Monici Preti, MD, Study Chair, Affiliation: Alfa Wassermann
Maria Grimaldi, MD, Study Director, Affiliation: Alfa Wassermann
Cosimo Prantera, MD, Principal Investigator, Affiliation: S. Camillo - Forlanini Hospital

Overall contact:
Maria Grimaldi, MD, Phone: +39 051 6489618, Email: MGrimaldi@alfawassermann.it

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical remission (Crohn's Disease Activity Index < 150 points)

Secondary outcome:

Clinical response (reduction of baseline CDAI score by 100 points or more)

Clinical response (reduction of baseline CDAI by 70 points or more)

Time to obtain clinical response and remission

Maintenance of clinical remission

Maintenance of clinical remission

Number of treatment failures

Definition of therapeutic dose to be used in subsequent phase III trials.

Adverse events

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Maria Grimaldi, MD, Phone: +39 051 6489618, Email: MGrimaldi@alfawassermann.it

CHU Grenoble, Hôpital Michallon, Grenoble Cedex 9 38043, France; Recruiting
Bruno Bonaz, MD, Principal Investigator

APHP, Hôpital Beaujon, Clichy 92110, France; Recruiting
Yoram Bouhnik, MD, Principal Investigator

CHU Amiens, Hôpital Nord, Amiens Cedex 80054, France; Recruiting
Jean-Louis Dupas, MD, Principal Investigator

CHU de Nice, Hôpital de l'Archet II, Nice Cedex 3 06202, France; Recruiting
Xavier Hébuterne, MD, Principal Investigator

CHU de Rouen, Hôpital Charles Nicolle, Rouen 76031, France; Recruiting
Eric Lerebours, MD, Principal Investigator

Hôpital Saint André, Bordeaux Cedex 33075, France; Recruiting
Frank Zerbib, MD, Principal Investigator

Charité Campus Mitte, Berlin D-10117, Germany; Recruiting
Herbert Lochs, MD Prof., Principal Investigator

Charité Campus Virchow-Klinikum, Berlin D-13353, Germany; Recruiting
Daniel Baumgart, MD, Principal Investigator

Universitätsklinikum Mannheim, Mannheim D-68167, Germany; Recruiting
Ulrich Boecker, MD, Principal Investigator

Gastroenterological Group Practice, Minden D-32423, Germany; Not yet recruiting
Bernd Bokemeyer, MD, Principal Investigator

Universitätsklinikum Rostock, Rostock D-18057, Germany; Not yet recruiting
Jörg Emmrich, MD, Principal Investigator

Universitätsklinikum Magdeburg, Magdeburg D-39120, Germany; Recruiting
Peter Malfertheiner, MD, Principal Investigator

Universitätsklinikum Freiburg, Freiburg D-79106, Germany; Not yet recruiting
Jens Rasenack, MD, Principal Investigator

Medizinische Hochschule Hannover, Hannover D-79106, Germany; Recruiting
Ursula Seidler, MD, Principal Investigator

Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin, Frankfurt/Main D-60596, Germany; Recruiting
Jürgen Stein, MD, Principal Investigator

Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika, Debrecen H-4012, Hungary; Recruiting
István Altorjay, MD, Principal Investigator

Baranya Megyei Kórház, Belgyógyászati és Gasztroenterológiai Osztály, Pecs H-7623, Hungary; Not yet recruiting
Tamás Beró, MD, Principal Investigator

Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika, Szeged H-6720, Hungary; Recruiting
Ferenc Nagy, MD, Principal Investigator

Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat, Gyula H-5700, Hungary; Recruiting
János Novák, MD, Principal Investigator

Petz Aladár Megyei Oktató Kórház, I. Belgyógyászat, Győr H-9023, Hungary; Not yet recruiting
István Rácz, MD, Principal Investigator

Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat, Szekszárd H-7100, Hungary; Recruiting
Ágnes Salamon, MD, Principal Investigator

Jávorszky Ödön Kórház, Gasztroenterológiai Osztály, Vác H-2601, Hungary; Recruiting
Tibor Szalóki, MD, Principal Investigator

Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza, Budapest H-1062, Hungary; Recruiting
Ferenc Zsigmond, MD, Principal Investigator

The Chaim Sheba Medical Center, Tel Hashomer 52621, Israel; Recruiting
Simon Bar-Meir, MD, Principal Investigator

Tel Aviv Sourasky Medical Center, Tel Aviv 64239, Israel; Recruiting
Iris Dotan, MD, Principal Investigator

Bnai Zion Medical Center, Haifa 31048, Israel; Recruiting
Alexandra Lavy, MD, Principal Investigator

Kaplan Medical Center, Rehovot 76100, Israel; Recruiting
Ehud Melzer, MD, Principal Investigator

Rabin Medical Center, Petah Tiqwa 49100, Israel; Recruiting
Yaron Niv, MD, Principal Investigator

Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi, Bologna 40138, Italy; Not yet recruiting
Massimo Campieri, MD, Prof., Principal Investigator

Policlinico "A,. Gemelli", Rome 00168, Italy; Not yet recruiting
Antonio Gasbarrini, MD, Principal Investigator

Ospedale Mauriziano "Umberto I", Turin 10128, Italy; Recruiting
Lucio Lombardo, MD, Principal Investigator

Azienda Ospedaliera Universitaria Policlinico di Torvergata, Rome 00133, Italy; Not yet recruiting
Francesco Pallone, MD, Principal Investigator

Azienda Ospedaliera "San Camillo-Forlanini", Rome 00149, Italy; Recruiting
Cosimo Prantera, MD Prof., Principal Investigator

Azienda Ospedaliera S. Giovanni Battista Molinette, Turin 10126, Italy; Not yet recruiting
Mario Rizzetto, MD, Principal Investigator

Azienda Ospedaliera Padova, Padova 35128, Italy; Recruiting
Giancarlo Sturniolo, MD, Principal Investigator

Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej, Katowice 40-752, Poland; Recruiting
Marek Hartleb, MD Prof., Principal Investigator

Szpital Specjalistyczny Św. Wojciecha- Adalberta, Gdańsk 80-462, Poland; Not yet recruiting
Mirosława Chełstowska, MD, PhD, Principal Investigator

Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny, Częstochowa 42-200, Poland; Recruiting
Zofia Jamrozik-Kruk, MD PhD, Principal Investigator

Samodzielny Publiczny Centralny Szpital Kliniczny, Warszawa 02-097, Poland; Recruiting
Waldemar Karnafel, MD Prof., Principal Investigator

Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego, Wroclaw 50-376, Poland; Recruiting
Leszek Paradowski, MD Prof., Principal Investigator

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Warszawa 02-781, Poland; Recruiting
Jaroslaw Regula, MD Prof., Principal Investigator

10 Wojskowy Szpital Kliniczny z Polikliniką, Bydgoszcz 85-681, Poland; Recruiting
Janusz Rudziński, MD Prof., Principal Investigator

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji, Warszawa 02-507, Poland; Not yet recruiting
Grażyna Rydzewska, MD Prof., Principal Investigator

Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod 603126, Russian Federation; Recruiting
Olga Alexeeva, MD, Principal Investigator

St. Petersburg MAPO, City Hospital #31, St. Petersburg 197110, Russian Federation; Recruiting
Andrey Baranovsky, MD, Principal Investigator

Military Medical Academy, St. Petersburg 193163, Russian Federation; Recruiting
Vladimir Grinevich, MD, Principal Investigator

Sechenov Moscow Medical Academy, Moscow 119881, Russian Federation; Recruiting
Vladimir Ivashkin, MD, Principal Investigator

Yaroslavl Regional Clinical Hospital, Yaroslavl 150062, Russian Federation; Recruiting
Oleg Khrustalev, MD, Principal Investigator

State Scientific Centre of Coloproctology, Moscow 123423, Russian Federation; Recruiting
Tatyana Mikhailova, MD, Principal Investigator

Russian Center of Functional Surgical Gastroenterology, Krasnodar 350086, Russian Federation; Recruiting
Vladimir Onopriev, MD, Principal Investigator

Novosibirsk State Medical University City Hospital #7, Novosibirsk 630005, Russian Federation; Recruiting
Marina Osipenko, MD, Principal Investigator

MAPO, City Hospital # 26, St. Petersburg 196247, Russian Federation; Recruiting
Vladimir Simanenkov, MD, Principal Investigator

Sokolov Clinical Hospital #122, St. Petersburg 194291, Russian Federation; Recruiting
Elena Sishkova, MD, Principal Investigator

City Polyclinic # 38, St. Petersburg 191015, Russian Federation; Recruiting
Boris Starostin, MD, Principal Investigator

St. Petersburg Mechnikov State Medical Academy, St. Petersburg 195067, Russian Federation; Recruiting
Evgeny Tkachenko, MD, Principal Investigator

Rostov State Medical University City Hospital # 20, Rostov-na-Donu 344091, Russian Federation; Not yet recruiting
Alexander Tkachev, MD, Principal Investigator

Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky, Moscow 129110, Russian Federation; Recruiting
Gennady Tsodikov, MD, Principal Investigator

City Clinical Hospital # 24, Moscow 127015, Russian Federation; Recruiting
Mikhail Yurkov, MD, Principal Investigator

Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Foggia 71013, Italy; Recruiting
Vito Annese, MD, Principal Investigator

Istituto Clinico Humanitas, Rozzano, Milan 20089, Italy; Recruiting
Silvio Danese, MD, Principal Investigator

Related 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.

Starting date: September 2007
Ending date: December 2008
Last updated: September 24, 2008