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

February 19, 2010 updated by: Alfasigma S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens Cedex, France, 80054
        • CHU Amiens, Hôpital Nord
      • Bordeaux Cedex, France, 33075
        • Hôpital Saint André
      • Grenoble Cedex 9, France, 38043
        • CHU Grenoble, Hôpital Michallon
      • Nice Cedex 3, France, 06202
        • CHU de Nice, Hôpital de l'Archet II
      • Rouen, France, 76031
        • CHU de Rouen, Hôpital Charles Nicolle
  • Germany
      • Berlin, Germany, D-10117
        • Charite Campus Mitte
      • Berlin, Germany, D-13353
        • Charité Campus Virchow-Klinikum
      • Frankfurt/Main, Germany, D-60596
        • Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin
      • Hannover, Germany, D-79106
        • Medizinische Hochschule Hannover
      • Hindenburgdamm 30, Berlin, Germany, 12200
        • Abteilung Gastroenterologie, Charité Campus Benjamin Franklin
      • Magdeburg, Germany, D-39120
        • Universitätsklinikum Magdeburg
      • Mannheim, Germany, D-68167
        • Universitätsklinikum Mannheim
      • Minden, Germany, D-32423
        • Gastroenterological Group Practice
  • Hungary
      • Budapest, Hungary, H-1062
        • Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza
      • Debrecen, Hungary, H-4012
        • Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika
      • Gyula, Hungary, H-5700
        • Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat
      • Szeged, Hungary, H-6720
        • Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika
      • Szekszárd, Hungary, H-7100
        • Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat
      • Vác, Hungary, H-2601
        • Javorszky Odon Korhaz, Gasztroenterologiai Osztaly
  • Israel
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Petah Tiqwa, Israel, 49100
        • Rabin Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi
      • Milan, Italy, 20157
        • A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74
      • Padova, Italy, 35128
        • Azienda Ospedaliera Padova
      • Rome, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico di Torvergata
      • Rome, Italy, 00149
        • Azienda Ospedaliera "San Camillo-Forlanini"
      • Rome, Italy, 00168
        • Policlinico "A,. Gemelli"
      • Turin, Italy, 10126
        • Azienda Ospedaliera S. Giovanni Battista Molinette
      • Turin, Italy, 10128
        • Ospedale Mauriziano "Umberto I"
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Casa Sollievo Della Sofferenza IRCCS
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Istituto Clinico Humanitas
  • Poland
      • Bydgoszcz, Poland, 85-681
        • 10 Wojskowy Szpital Kliniczny z Polikliniką
      • Częstochowa, Poland, 42-200
        • Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny
      • Gdańsk, Poland, 80-462
        • Szpital Specjalistyczny Św. Wojciecha- Adalberta
      • Katowice, Poland, 40-752
        • Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej
      • Warszawa, Poland, 02-097
        • Samodzielny Publiczny Centralny Szpital Kliniczny
      • Warszawa, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
      • Wroclaw, Poland, 50-376
        • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Russian Federation
      • Krasnodar, Russian Federation, 350086
        • Russian Center of Functional Surgical Gastroenterology
      • Moscow, Russian Federation, 123423
        • State Scientific Centre of Coloproctology
      • Moscow, Russian Federation, 119881
        • Sechenov Moscow Medical Academy
      • Moscow, Russian Federation, 127015
        • City Clinical Hospital # 24
      • Moscow, Russian Federation, 129110
        • Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky
      • Nizhny Novgorod, Russian Federation, 603126
        • Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk, Russian Federation, 630005
        • Novosibirsk State Medical University City Hospital #7
      • Rostov-na-Donu, Russian Federation, 344091
        • Rostov State Medical University City Hospital # 20
      • St. Petersburg, Russian Federation, 191015
        • City Polyclinic # 38
      • St. Petersburg, Russian Federation, 193163
        • Military Medical Academy
      • St. Petersburg, Russian Federation, 194291
        • Sokolov Clinical Hospital #122
      • St. Petersburg, Russian Federation, 195067
        • St. Petersburg Mechnikov State Medical Academy
      • St. Petersburg, Russian Federation, 196247
        • MAPO, City Hospital # 26
      • St. Petersburg, Russian Federation, 197110
        • St. Petersburg MAPO, City Hospital #31
      • Yaroslavl, Russian Federation, 150062
        • Yaroslavl Regional Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Other Names:
  • GRACE
Experimental: B
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
Other Names:
  • GRACE
Experimental: C
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
Other Names:
  • GRACE
Placebo Comparator: D
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
Other Names:
  • GRACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical remission (Crohn's Disease Activity Index < 150 points)
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response (reduction of baseline CDAI score by 100 points or more)
Time Frame: Any time during the 12 weeks of treament
Any time during the 12 weeks of treament
Clinical response (reduction of baseline CDAI by 70 points or more)
Time Frame: At any time during the 12 weeks of treatment
At any time during the 12 weeks of treatment
Time to obtain clinical response and remission
Time Frame: During the 12 weeks of treatment
During the 12 weeks of treatment
Maintenance of clinical remission
Time Frame: 2 weeks after the end of the 12 weeks of treatment
2 weeks after the end of the 12 weeks of treatment
Maintenance of clinical remission
Time Frame: 12 weeks after the end of the 12 weeks of treatment
12 weeks after the end of the 12 weeks of treatment
Number of treatment failures
Time Frame: During the 12 weeks of treatment
During the 12 weeks of treatment
Definition of therapeutic dose to be used in subsequent phase III trials.
Time Frame: After statistical analysis of the results
After statistical analysis of the results
Adverse events
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfasigma 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 19, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETIC/03/06
  • EudraCT: 2007-001014-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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