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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528073
• Other study ID #: RETIC/03/06
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2007
• Last updated: February 19, 2010
• Start date: September 2007
• Est. completion date: October 2009

Study information

• Verified date: February 2010
• Source: Alfa Wassermann S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: October 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens, Hôpital Nord	Amiens Cedex
France	Hôpital Saint André	Bordeaux Cedex
France	CHU Grenoble, Hôpital Michallon	Grenoble Cedex 9
France	CHU de Nice, Hôpital de l'Archet II	Nice Cedex 3
France	CHU de Rouen, Hôpital Charles Nicolle	Rouen
Germany	Charité Campus Mitte	Berlin
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin	Frankfurt/Main
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Abteilung Gastroenterologie, Charité Campus Benjamin Franklin	Hindenburgdamm 30, Berlin
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Gastroenterological Group Practice	Minden
Hungary	Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza	Budapest
Hungary	Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika	Debrecen
Hungary	Békés Megyei Kèpviselotestület, Pándy Kálmán Kórház, III. Belgyógyászat	Gyula
Hungary	Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika	Szeged
Hungary	Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat	Szekszárd
Hungary	Jávorszky Ödön Kórház, Gasztroenterológiai Osztály	Vác
Israel	Bnai Zion Medical Center	Haifa
Israel	Rabin Medical Center	Petah Tiqwa
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Italy	Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi	Bologna
Italy	A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74	Milan
Italy	Azienda Ospedaliera Padova	Padova
Italy	Azienda Ospedaliera "San Camillo-Forlanini"	Rome
Italy	Azienda Ospedaliera Universitaria Policlinico di Torvergata	Rome
Italy	Policlinico "A,. Gemelli"	Rome
Italy	Istituto Clinico Humanitas	Rozzano	Milan
Italy	Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo	Foggia
Italy	Azienda Ospedaliera S. Giovanni Battista Molinette	Turin
Italy	Ospedale Mauriziano "Umberto I"	Turin
Poland	10 Wojskowy Szpital Kliniczny z Poliklinika	Bydgoszcz
Poland	Wojewódzki Szpital Specjalistyczny im. Najswietszej Maryi Panny	Czestochowa
Poland	Szpital Specjalistyczny Sw. Wojciecha- Adalberta	Gdansk
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Slaskiej Akademii Medycznej	Katowice
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji	Warszawa
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Warszawa
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny	Warszawa
Poland	Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego	Wroclaw
Russian Federation	Russian Center of Functional Surgical Gastroenterology	Krasnodar
Russian Federation	City Clinical Hospital # 24	Moscow
Russian Federation	Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky	Moscow
Russian Federation	Sechenov Moscow Medical Academy	Moscow
Russian Federation	State Scientific Centre of Coloproctology	Moscow
Russian Federation	Nizhny Novgorod Regional Clinical Hospital	Nizhny Novgorod
Russian Federation	Novosibirsk State Medical University City Hospital #7	Novosibirsk
Russian Federation	Rostov State Medical University City Hospital # 20	Rostov-na-Donu
Russian Federation	City Polyclinic # 38	St. Petersburg
Russian Federation	MAPO, City Hospital # 26	St. Petersburg
Russian Federation	Military Medical Academy	St. Petersburg
Russian Federation	Sokolov Clinical Hospital #122	St. Petersburg
Russian Federation	St. Petersburg MAPO, City Hospital #31	St. Petersburg
Russian Federation	St. Petersburg Mechnikov State Medical Academy	St. Petersburg
Russian Federation	Yaroslavl Regional Clinical Hospital	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Alfa Wassermann S.p.A.

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission (Crohn's Disease Activity Index < 150 points)		After 12 weeks of treatment	No
Secondary	Clinical response (reduction of baseline CDAI score by 100 points or more)		Any time during the 12 weeks of treament	No
Secondary	Clinical response (reduction of baseline CDAI by 70 points or more)		At any time during the 12 weeks of treatment	No
Secondary	Time to obtain clinical response and remission		During the 12 weeks of treatment	No
Secondary	Maintenance of clinical remission		2 weeks after the end of the 12 weeks of treatment	No
Secondary	Maintenance of clinical remission		12 weeks after the end of the 12 weeks of treatment	No
Secondary	Number of treatment failures		During the 12 weeks of treatment	No
Secondary	Definition of therapeutic dose to be used in subsequent phase III trials.		After statistical analysis of the results	No
Secondary	Adverse events		Throughout the study	Yes