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

NCT00528073 | Completed Phase 2 DMC

• 2 other identifiers: RETIC/03/06EudraCT: 2007-001014-17
• Study Type: interventional
• Target: 410
• Locations: 7 countries
• Sites: 57

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

Rifaximin-EIR; Crohn's disease; remission

Outcome Measures

Primary Outcomes (1)

• Clinical remission (Crohn's Disease Activity Index < 150 points)

  After 12 weeks of treatment

Secondary Outcomes (8)

• 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

• 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

Study Arms (4)

A

EXPERIMENTAL

Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid

Drug: Rifaximin-EIR

B

EXPERIMENTAL

Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid

Drug: Rifaximin-EIR

C

EXPERIMENTAL

Rifaximin-EIR tablet 3x400 mg bid

Drug: Rifaximin-EIR

D

PLACEBO COMPARATOR

Placebo 3 tablets bid

Drug: Rifaximin-EIR

Interventions

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

Also known as: GRACE

A; B; C; D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (57)

CHU Amiens, Hôpital Nord

Amiens, 80054, France

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

CHU Grenoble, Hôpital Michallon

Grenoble, 38043, France

Location

CHU de Nice, Hôpital de l'Archet II

Nice, 06202, France

Location

CHU de Rouen, Hôpital Charles Nicolle

Rouen, 76031, France

Location

Charité Campus Mitte

Berlin, D-10117, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, D-13353, Germany

Location

Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin

Frankfurt am Main, D-60596, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-79106, Germany

Location

Abteilung Gastroenterologie, Charité Campus Benjamin Franklin

Hindenburgdamm 30, Berlin, 12200, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, D-39120, Germany

Location

Universitätsklinikum Mannheim

Mannheim, D-68167, Germany

Location

Gastroenterological Group Practice

Minden, D-32423, Germany

Location

Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza

Budapest, H-1062, Hungary

Location

Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika

Debrecen, H-4012, Hungary

Location

Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat

Gyula, H-5700, Hungary

Location

Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika

Szeged, H-6720, Hungary

Location

Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat

Szekszárd, H-7100, Hungary

Location

Jávorszky Ödön Kórház, Gasztroenterológiai Osztály

Vác, H-2601, Hungary

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74

Milan, 20157, Italy

Location

Azienda Ospedaliera Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Universitaria Policlinico di Torvergata

Rome, 00133, Italy

Location

Azienda Ospedaliera "San Camillo-Forlanini"

Rome, 00149, Italy

Location

Policlinico "A,. Gemelli"

Rome, 00168, Italy

Location

Azienda Ospedaliera S. Giovanni Battista Molinette

Turin, 10126, Italy

Location

Ospedale Mauriziano "Umberto I"

Turin, 10128, Italy

Location

10 Wojskowy Szpital Kliniczny z Polikliniką

Bydgoszcz, 85-681, Poland

Location

Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny

Częstochowa, 42-200, Poland

Location

Szpital Specjalistyczny Św. Wojciecha- Adalberta

Gdansk, 80-462, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej

Katowice, 40-752, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, 02-097, Poland

Location

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji

Warsaw, 02-507, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

Wroclaw, 50-376, Poland

Location

Russian Center of Functional Surgical Gastroenterology

Krasnodar, 350086, Russia

Location

Sechenov Moscow Medical Academy

Moscow, 119881, Russia

Location

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

City Clinical Hospital # 24

Moscow, 127015, Russia

Location

Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky

Moscow, 129110, Russia

Location

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, 603126, Russia

Location

Novosibirsk State Medical University City Hospital #7

Novosibirsk, 630005, Russia

Location

Rostov State Medical University City Hospital # 20

Rostov-on-Don, 344091, Russia

Location

City Polyclinic # 38

Saint Petersburg, 191015, Russia

Location

Military Medical Academy

Saint Petersburg, 193163, Russia

Location

Sokolov Clinical Hospital #122

Saint Petersburg, 194291, Russia

Location

St. Petersburg Mechnikov State Medical Academy

Saint Petersburg, 195067, Russia

Location

MAPO, City Hospital # 26

Saint Petersburg, 196247, Russia

Location

St. Petersburg MAPO, City Hospital #31

Saint Petersburg, 197110, Russia

Location

Yaroslavl Regional Clinical Hospital

Yaroslavl, 150062, Russia

Location

Related Publications (2)

• 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.

  PMID: 16611272 BACKGROUND

• 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.

  PMID: 22155172 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 22, 2010

Record last verified: 2010-02

Locations

FR (5); IL (5); DE (8); PL (8); RU (15); HU (6); IT (10)