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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2007-001014-17 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid |
|
| B | Experimental | Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid |
|
| C | Experimental | Rifaximin-EIR tablet 3x400 mg bid |
|
| D | Placebo Comparator | Placebo 3 tablets bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin-EIR | Drug | Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission (Crohn's Disease Activity Index < 150 points) | After 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pier Alessandro Monici Preti, MD | Alfa Wassermann | Study Chair |
| Maria Grimaldi, MD | Alfa Wassermann | Study Director |
| Cosimo Prantera, MD | S. Camillo - Forlanini Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens, Hôpital Nord | Amiens | 80054 | France | |||
| Hôpital Saint André |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16611272 | Background | 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. | |
| 22155172 | Derived |
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|
| Time to obtain clinical response and remission | During the 12 weeks of treatment |
| Maintenance of clinical remission | 2 weeks after the end of 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 |
| Bordeaux |
| 33075 |
| France |
| CHU Grenoble, Hôpital Michallon | Grenoble | 38043 | France |
| CHU de Nice, Hôpital de l'Archet II | Nice | 06202 | France |
| CHU de Rouen, Hôpital Charles Nicolle | Rouen | 76031 | France |
| Charité Campus Mitte | Berlin | D-10117 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | D-13353 | Germany |
| Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin | Frankfurt am Main | D-60596 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-79106 | Germany |
| Abteilung Gastroenterologie, Charité Campus Benjamin Franklin | Hindenburgdamm 30, Berlin | 12200 | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | D-39120 | Germany |
| Universitätsklinikum Mannheim | Mannheim | D-68167 | Germany |
| Gastroenterological Group Practice | Minden | D-32423 | Germany |
| Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza | Budapest | H-1062 | Hungary |
| Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika | Debrecen | H-4012 | Hungary |
| Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat | Gyula | H-5700 | Hungary |
| Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika | Szeged | H-6720 | Hungary |
| Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat | Szekszárd | H-7100 | Hungary |
| Jávorszky Ödön Kórház, Gasztroenterológiai Osztály | Vác | H-2601 | Hungary |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Casa Sollievo della Sofferenza IRCCS | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milan | 20089 | Italy |
| Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi | Bologna | 40138 | Italy |
| A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74 | Milan | 20157 | Italy |
| Azienda Ospedaliera Padova | Padova | 35128 | Italy |
| Azienda Ospedaliera Universitaria Policlinico di Torvergata | Rome | 00133 | Italy |
| Azienda Ospedaliera "San Camillo-Forlanini" | Rome | 00149 | Italy |
| Policlinico "A,. Gemelli" | Rome | 00168 | Italy |
| Azienda Ospedaliera S. Giovanni Battista Molinette | Turin | 10126 | Italy |
| Ospedale Mauriziano "Umberto I" | Turin | 10128 | Italy |
| 10 Wojskowy Szpital Kliniczny z Polikliniką | Bydgoszcz | 85-681 | Poland |
| Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny | Częstochowa | 42-200 | Poland |
| Szpital Specjalistyczny Św. Wojciecha- Adalberta | Gdansk | 80-462 | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej | Katowice | 40-752 | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny | Warsaw | 02-097 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji | Warsaw | 02-507 | Poland |
| Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego | Wroclaw | 50-376 | Poland |
| Russian Center of Functional Surgical Gastroenterology | Krasnodar | 350086 | Russia |
| Sechenov Moscow Medical Academy | Moscow | 119881 | Russia |
| State Scientific Centre of Coloproctology | Moscow | 123423 | Russia |
| City Clinical Hospital # 24 | Moscow | 127015 | Russia |
| Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky | Moscow | 129110 | Russia |
| Nizhny Novgorod Regional Clinical Hospital | Nizhny Novgorod | 603126 | Russia |
| Novosibirsk State Medical University City Hospital #7 | Novosibirsk | 630005 | Russia |
| Rostov State Medical University City Hospital # 20 | Rostov-on-Don | 344091 | Russia |
| City Polyclinic # 38 | Saint Petersburg | 191015 | Russia |
| Military Medical Academy | Saint Petersburg | 193163 | Russia |
| Sokolov Clinical Hospital #122 | Saint Petersburg | 194291 | Russia |
| St. Petersburg Mechnikov State Medical Academy | Saint Petersburg | 195067 | Russia |
| MAPO, City Hospital # 26 | Saint Petersburg | 196247 | Russia |
| St. Petersburg MAPO, City Hospital #31 | Saint Petersburg | 197110 | Russia |
| Yaroslavl Regional Clinical Hospital | Yaroslavl | 150062 | Russia |
| 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. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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