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| 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: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 410 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | October 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
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
|
|
B: Experimental
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
|
|
C: Experimental
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
|
|
D: Placebo Comparator
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| France | |
| CHU Grenoble, Hôpital Michallon | |
| Grenoble Cedex 9, France, 38043 | |
| CHU Amiens, Hôpital Nord | |
| Amiens Cedex, France, 80054 | |
| CHU de Nice, Hôpital de l'Archet II | |
| Nice Cedex 3, France, 06202 | |
| CHU de Rouen, Hôpital Charles Nicolle | |
| Rouen, France, 76031 | |
| Hôpital Saint André | |
| Bordeaux Cedex, France, 33075 | |
| Germany | |
| Charité Campus Mitte | |
| Berlin, Germany, D-10117 | |
| Charité Campus Virchow-Klinikum | |
| Berlin, Germany, D-13353 | |
| Universitätsklinikum Mannheim | |
| Mannheim, Germany, D-68167 | |
| Gastroenterological Group Practice | |
| Minden, Germany, D-32423 | |
| Universitätsklinikum Magdeburg | |
| Magdeburg, Germany, D-39120 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-79106 | |
| Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin | |
| Frankfurt/Main, Germany, D-60596 | |
| Abteilung Gastroenterologie, Charité Campus Benjamin Franklin | |
| Hindenburgdamm 30, Berlin, Germany, 12200 | |
| Hungary | |
| Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika | |
| Debrecen, Hungary, H-4012 | |
| Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika | |
| Szeged, Hungary, H-6720 | |
| Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat | |
| Gyula, Hungary, H-5700 | |
| Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat | |
| Szekszárd, Hungary, H-7100 | |
| Jávorszky Ödön Kórház, Gasztroenterológiai Osztály | |
| Vác, Hungary, H-2601 | |
| Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza | |
| Budapest, Hungary, H-1062 | |
| Israel | |
| The Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Tel Aviv Sourasky Medical Center | |
| Tel Aviv, Israel, 64239 | |
| Bnai Zion Medical Center | |
| Haifa, Israel, 31048 | |
| Kaplan Medical Center | |
| Rehovot, Israel, 76100 | |
| Rabin Medical Center | |
| Petah Tiqwa, Israel, 49100 | |
| Italy | |
| Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi | |
| Bologna, Italy, 40138 | |
| Azienda Ospedaliera Universitaria Policlinico di Torvergata | |
| Rome, Italy, 00133 | |
| Ospedale Mauriziano "Umberto I" | |
| Turin, Italy, 10128 | |
| Policlinico "A,. Gemelli" | |
| Rome, Italy, 00168 | |
| Azienda Ospedaliera "San Camillo-Forlanini" | |
| Rome, Italy, 00149 | |
| Azienda Ospedaliera S. Giovanni Battista Molinette | |
| Turin, Italy, 10126 | |
| Azienda Ospedaliera Padova | |
| Padova, Italy, 35128 | |
| A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74 | |
| Milan, Italy, 20157 | |
| Italy, Foggia | |
| Casa Sollievo della Sofferenza IRCCS | |
| San Giovanni Rotondo, Foggia, Italy, 71013 | |
| Italy, Milan | |
| Istituto Clinico Humanitas | |
| Rozzano, Milan, Italy, 20089 | |
| Poland | |
| Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej | |
| Katowice, Poland, 40-752 | |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji | |
| Warszawa, Poland, 02-507 | |
| Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny | |
| Częstochowa, Poland, 42-200 | |
| Samodzielny Publiczny Centralny Szpital Kliniczny | |
| Warszawa, Poland, 02-097 | |
| Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego | |
| Wroclaw, Poland, 50-376 | |
| Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | |
| Warszawa, Poland, 02-781 | |
| 10 Wojskowy Szpital Kliniczny z Polikliniką | |
| Bydgoszcz, Poland, 85-681 | |
| Szpital Specjalistyczny Św. Wojciecha- Adalberta | |
| Gdańsk, Poland, 80-462 | |
| Russian Federation | |
| Nizhny Novgorod Regional Clinical Hospital | |
| Nizhny Novgorod, Russian Federation, 603126 | |
| City Clinical Hospital # 24 | |
| Moscow, Russian Federation, 127015 | |
| Military Medical Academy | |
| St. Petersburg, Russian Federation, 193163 | |
| Sechenov Moscow Medical Academy | |
| Moscow, Russian Federation, 119881 | |
| Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, Russian Federation, 150062 | |
| State Scientific Centre of Coloproctology | |
| Moscow, Russian Federation, 123423 | |
| Russian Center of Functional Surgical Gastroenterology | |
| Krasnodar, Russian Federation, 350086 | |
| Novosibirsk State Medical University City Hospital #7 | |
| Novosibirsk, Russian Federation, 630005 | |
| MAPO, City Hospital # 26 | |
| St. Petersburg, Russian Federation, 196247 | |
| Sokolov Clinical Hospital #122 | |
| St. Petersburg, Russian Federation, 194291 | |
| City Polyclinic # 38 | |
| St. Petersburg, Russian Federation, 191015 | |
| St. Petersburg Mechnikov State Medical Academy | |
| St. Petersburg, Russian Federation, 195067 | |
| Rostov State Medical University City Hospital # 20 | |
| Rostov-na-Donu, Russian Federation, 344091 | |
| Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky | |
| Moscow, Russian Federation, 129110 | |
| St. Petersburg MAPO, City Hospital #31 | |
| St. Petersburg, Russian Federation, 197110 | |
| 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
| Responsible Party: | Alfa Wassermann S.p.A. ( Dr Pier Alessandro Monici Preti MD ) |
| Study ID Numbers: | RETIC/03/06, EudraCT: 2007-001014-17 |
| Study First Received: | September 10, 2007 |
| Last Updated: | April 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00528073 History of Changes |
| 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 |
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Rifaximin-EIR Crohn's disease remission |
|
Anti-Infective Agents Digestive System Diseases Gastrointestinal Diseases Therapeutic Uses Crohn Disease Gastrointestinal Agents |
Inflammatory Bowel Diseases Rifaximin Intestinal Diseases Gastroenteritis Pharmacologic Actions |