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Crohn's DiseasePhase 2NCT00528073

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

A Phase 2 study testing Rifaximin-EIR in people with Crohn's Disease, run by Alfasigma S.p.A. at 57 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
Rifaximin-EIR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
410 participants
Where
57 sitesin 7 countries
Study dates
Sep 2007to Oct 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 18Show fewer
  • 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.

Trial locations and contacts

57 sites in 7 countries.

57 sites in 7 countries

Russia15 sites

  • Russian Center of Functional Surgical Gastroenterology

    Krasnodar, 350086

  • Sechenov Moscow Medical Academy

    Moscow, 119881

  • State Scientific Centre of Coloproctology

    Moscow, 123423

  • City Clinical Hospital # 24

    Moscow, 127015

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

    Moscow, 129110

  • Nizhny Novgorod Regional Clinical Hospital

    Nizhny Novgorod, 603126

  • Novosibirsk State Medical University City Hospital #7

    Novosibirsk, 630005

  • Rostov State Medical University City Hospital # 20

    Rostov-on-Don, 344091

  • City Polyclinic # 38

    Saint Petersburg, 191015

  • Military Medical Academy

    Saint Petersburg, 193163

  • Sokolov Clinical Hospital #122

    Saint Petersburg, 194291

  • St. Petersburg Mechnikov State Medical Academy

    Saint Petersburg, 195067

  • MAPO, City Hospital # 26

    Saint Petersburg, 196247

  • St. Petersburg MAPO, City Hospital #31

    Saint Petersburg, 197110

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150062

Other trials in Russia

Italy10 sites

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

    Bologna, 40138

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

    Milan, 20157

  • Azienda Ospedaliera Padova

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico di Torvergata

    Rome, 00133

  • Azienda Ospedaliera "San Camillo-Forlanini"

    Rome, 00149

  • Policlinico "A,. Gemelli"

    Rome, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milan, 20089

  • Casa Sollievo della Sofferenza IRCCS

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliera S. Giovanni Battista Molinette

    Turin, 10126

  • Ospedale Mauriziano "Umberto I"

    Turin, 10128

Other trials in Italy

Germany8 sites

  • Charité Campus Mitte

    Berlin, D-10117

  • Charité Campus Virchow-Klinikum

    Berlin, D-13353

  • Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin

    Frankfurt am Main, D-60596

  • Medizinische Hochschule Hannover

    Hanover, D-79106

  • Abteilung Gastroenterologie, Charité Campus Benjamin Franklin

    Hindenburgdamm 30, Berlin, 12200

  • Universitätsklinikum Magdeburg

    Magdeburg, D-39120

  • Universitätsklinikum Mannheim

    Mannheim, D-68167

  • Gastroenterological Group Practice

    Minden, D-32423

Other trials in Germany

Poland8 sites

  • 10 Wojskowy Szpital Kliniczny z Polikliniką

    Bydgoszcz, 85-681

  • Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny

    Częstochowa, 42-200

  • Szpital Specjalistyczny Św. Wojciecha- Adalberta

    Gdansk, 80-462

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

    Katowice, 40-752

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw, 02-097

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji

    Warsaw, 02-507

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-376

Other trials in Poland

Hungary6 sites

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

    Budapest, H-1062

  • Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika

    Debrecen, H-4012

  • Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat

    Gyula, H-5700

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

    Szeged, H-6720

  • Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat

    Szekszárd, H-7100

  • Jávorszky Ödön Kórház, Gasztroenterológiai Osztály

    Vác, H-2601

Other trials in Hungary

France5 sites

  • CHU Amiens, Hôpital Nord

    Amiens, 80054

  • Hôpital Saint André

    Bordeaux, 33075

  • CHU Grenoble, Hôpital Michallon

    Grenoble, 38043

  • CHU de Nice, Hôpital de l'Archet II

    Nice, 06202

  • CHU de Rouen, Hôpital Charles Nicolle

    Rouen, 76031

Other trials in France

Israel5 sites

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

About this 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

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
Being tested
Rifaximin-EIR
Keywords
Rifaximin-EIR, Crohn's disease, remission
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rifaximin-EIRDrug

    Also called GRACE

    Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease

Study groups in NCT00528073
Study groupRoleWhat they receive
AExperimentalRifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid
Receives: Drug: Rifaximin-EIR
BExperimentalRifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid
Receives: Drug: Rifaximin-EIR
CExperimentalRifaximin-EIR tablet 3x400 mg bid
Receives: Drug: Rifaximin-EIR
DPlacebo comparatorPlacebo 3 tablets bid
Receives: Drug: Rifaximin-EIR

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: After 12 weeks of treatment

Secondary outcomes (8)

  1. Clinical response (reduction of baseline CDAI score by 100 points or more)

    Measured: Any time during the 12 weeks of treament

  2. Clinical response (reduction of baseline CDAI by 70 points or more)

    Measured: At any time during the 12 weeks of treatment

  3. Time to obtain clinical response and remission

    Measured: During the 12 weeks of treatment

  4. Maintenance of clinical remission

    Measured: 2 weeks after the end of the 12 weeks of treatment

  5. Maintenance of clinical remission

    Measured: 12 weeks after the end of the 12 weeks of treatment

  6. Number of treatment failures

    Measured: During the 12 weeks of treatment

  7. Definition of therapeutic dose to be used in subsequent phase III trials.

    Measured: After statistical analysis of the results

  8. Adverse events

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionMar 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528073
Sponsor's protocol ID
RETIC/03/06
Other IDs
EudraCT: 2007-001014-17
Status last verified
Feb 2010
First submitted
10 Sep 2007
Last updated
22 Feb 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16611272

  • 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.

    PubMed 22155172

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifaximin-EIR in people with Crohn's Disease, run by Alfasigma S.p.A. at 57 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Russia, Italy, Germany, Poland, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical remission (Crohn's Disease Activity Index < 150 points) (time frame: After 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00528073, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2010.

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