Back to resultsPlacebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rifaximin-EIR
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Rifaximin-EIR, Crohn's disease, remission
Eligibility 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.
Sites / Locations
- CHU Amiens, Hôpital Nord
- Hôpital Saint André
- CHU Grenoble, Hôpital Michallon
- CHU de Nice, Hôpital de l'Archet II
- CHU de Rouen, Hôpital Charles Nicolle
- Charité Campus Mitte
- Charité Campus Virchow-Klinikum
- Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin
- Medizinische Hochschule Hannover
- Abteilung Gastroenterologie, Charité Campus Benjamin Franklin
- Universitätsklinikum Magdeburg
- Universitätsklinikum Mannheim
- Gastroenterological Group Practice
- Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza
- Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika
- Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat
- Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika
- Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat
- Jávorszky Ödön Kórház, Gasztroenterológiai Osztály
- Bnai Zion Medical Center
- Rabin Medical Center
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center
- The Chaim Sheba Medical Center
- Casa Sollievo della Sofferenza IRCCS
- Istituto Clinico Humanitas
- Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi
- A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74
- Azienda Ospedaliera Padova
- Azienda Ospedaliera Universitaria Policlinico di Torvergata
- Azienda Ospedaliera "San Camillo-Forlanini"
- Policlinico "A,. Gemelli"
- Azienda Ospedaliera S. Giovanni Battista Molinette
- Ospedale Mauriziano "Umberto I"
- 10 Wojskowy Szpital Kliniczny z Polikliniką
- Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny
- Szpital Specjalistyczny Św. Wojciecha- Adalberta
- Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej
- Samodzielny Publiczny Centralny Szpital Kliniczny
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji
- Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
- Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
- Russian Center of Functional Surgical Gastroenterology
- Sechenov Moscow Medical Academy
- State Scientific Centre of Coloproctology
- City Clinical Hospital # 24
- Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky
- Nizhny Novgorod Regional Clinical Hospital
- Novosibirsk State Medical University City Hospital #7
- Rostov State Medical University City Hospital # 20
- City Polyclinic # 38
- Military Medical Academy
- Sokolov Clinical Hospital #122
- St. Petersburg Mechnikov State Medical Academy
- MAPO, City Hospital # 26
- St. Petersburg MAPO, City Hospital #31
- Yaroslavl Regional Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
A
B
C
D
Arm Description
Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid
Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid
Rifaximin-EIR tablet 3x400 mg bid
Placebo 3 tablets bid
Outcomes
Primary Outcome Measures
Clinical remission (Crohn's Disease Activity Index < 150 points)
Secondary Outcome Measures
Clinical response (reduction of baseline CDAI score by 100 points or more)
Clinical response (reduction of baseline CDAI by 70 points or more)
Time to obtain clinical response and remission
Maintenance of clinical remission
Maintenance of clinical remission
Number of treatment failures
Definition of therapeutic dose to be used in subsequent phase III trials.
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00528073
Brief Title
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alfasigma S.p.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Rifaximin-EIR, Crohn's disease, remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid
Arm Title
B
Arm Type
Experimental
Arm Description
Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid
Arm Title
C
Arm Type
Experimental
Arm Description
Rifaximin-EIR tablet 3x400 mg bid
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
Placebo 3 tablets bid
Intervention Type
Drug
Intervention Name(s)
Rifaximin-EIR
Other Intervention Name(s)
GRACE
Intervention Description
Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease
Primary Outcome Measure Information:
Title
Clinical remission (Crohn's Disease Activity Index < 150 points)
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Clinical response (reduction of baseline CDAI score by 100 points or more)
Time Frame
Any time during the 12 weeks of treament
Title
Clinical response (reduction of baseline CDAI by 70 points or more)
Time Frame
At any time during the 12 weeks of treatment
Title
Time to obtain clinical response and remission
Time Frame
During the 12 weeks of treatment
Title
Maintenance of clinical remission
Time Frame
2 weeks after the end of the 12 weeks of treatment
Title
Maintenance of clinical remission
Time Frame
12 weeks after the end of the 12 weeks of treatment
Title
Number of treatment failures
Time Frame
During the 12 weeks of treatment
Title
Definition of therapeutic dose to be used in subsequent phase III trials.
Time Frame
After statistical analysis of the results
Title
Adverse events
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pier Alessandro Monici Preti, MD
Organizational Affiliation
Alfa Wassermann
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Grimaldi, MD
Organizational Affiliation
Alfa Wassermann
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cosimo Prantera, MD
Organizational Affiliation
S. Camillo - Forlanini Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens, Hôpital Nord
City
Amiens Cedex
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital Saint André
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
CHU Grenoble, Hôpital Michallon
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de Nice, Hôpital de l'Archet II
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Rouen, Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin
City
Frankfurt/Main
ZIP/Postal Code
D-60596
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Abteilung Gastroenterologie, Charité Campus Benjamin Franklin
City
Hindenburgdamm 30, Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39120
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
D-68167
Country
Germany
Facility Name
Gastroenterological Group Practice
City
Minden
ZIP/Postal Code
D-32423
Country
Germany
Facility Name
Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Facility Name
Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat
City
Gyula
ZIP/Postal Code
H-5700
Country
Hungary
Facility Name
Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat
City
Szekszárd
ZIP/Postal Code
H-7100
Country
Hungary
Facility Name
Jávorszky Ödön Kórház, Gasztroenterológiai Osztály
City
Vác
ZIP/Postal Code
H-2601
Country
Hungary
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Casa Sollievo della Sofferenza IRCCS
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico di Torvergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera "San Camillo-Forlanini"
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Policlinico "A,. Gemelli"
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera S. Giovanni Battista Molinette
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Mauriziano "Umberto I"
City
Turin
ZIP/Postal Code
10128
Country
Italy
Facility Name
10 Wojskowy Szpital Kliniczny z Polikliniką
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny
City
Częstochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Szpital Specjalistyczny Św. Wojciecha- Adalberta
City
Gdańsk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
City
Wroclaw
ZIP/Postal Code
50-376
Country
Poland
Facility Name
Russian Center of Functional Surgical Gastroenterology
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Sechenov Moscow Medical Academy
City
Moscow
ZIP/Postal Code
119881
Country
Russian Federation
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
City Clinical Hospital # 24
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Nizhny Novgorod Regional Clinical Hospital
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novosibirsk State Medical University City Hospital #7
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Rostov State Medical University City Hospital # 20
City
Rostov-na-Donu
ZIP/Postal Code
344091
Country
Russian Federation
Facility Name
City Polyclinic # 38
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Military Medical Academy
City
St. Petersburg
ZIP/Postal Code
193163
Country
Russian Federation
Facility Name
Sokolov Clinical Hospital #122
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St. Petersburg Mechnikov State Medical Academy
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
MAPO, City Hospital # 26
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
St. Petersburg MAPO, City Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
16611272
Citation
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.
Results Reference
background
PubMed Identifier
22155172
Citation
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.
Results Reference
derived
Learn more about this trial
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
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