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Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
This study is ongoing, but not recruiting participants.
First Received: September 10, 2007   Last Updated: April 20, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Alfa Wassermann S.p.A.:

Primary Outcome Measures:
  • Clinical remission (Crohn's Disease Activity Index < 150 points) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response (reduction of baseline CDAI score by 100 points or more) [ Time Frame: Any time during the 12 weeks of treament ] [ Designated as safety issue: No ]
  • Clinical response (reduction of baseline CDAI by 70 points or more) [ Time Frame: At any time during the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Time to obtain clinical response and remission [ Time Frame: During the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Maintenance of clinical remission [ Time Frame: 2 weeks after the end of the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Maintenance of clinical remission [ Time Frame: 12 weeks after the end of the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment failures [ Time Frame: During the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Definition of therapeutic dose to be used in subsequent phase III trials. [ Time Frame: After statistical analysis of the results ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528073

  Hide Study Locations
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
Sponsors and Collaborators
Alfa Wassermann S.p.A.
Investigators
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

Publications:
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

Keywords provided by Alfa Wassermann S.p.A.:
Rifaximin-EIR
Crohn's disease
remission

Additional relevant MeSH terms:
Anti-Infective Agents
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Crohn Disease
Gastrointestinal Agents
Inflammatory Bowel Diseases
Rifaximin
Intestinal Diseases
Gastroenteritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009