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

This study has been completed.
Sponsor:
Information provided by:
Alfa Wassermann S.p.A.
ClinicalTrials.gov Identifier:
NCT00528073
First received: September 10, 2007
Last updated: February 19, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: Rifaximin-EIR
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alfa Wassermann S.p.A.:

Primary Outcome Measures:
  • Clinical remission (Crohn's Disease Activity Index < 150 points) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response (reduction of baseline CDAI score by 100 points or more) [ Time Frame: Any time during the 12 weeks of treament ] [ Designated as safety issue: No ]
  • Clinical response (reduction of baseline CDAI by 70 points or more) [ Time Frame: At any time during the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Time to obtain clinical response and remission [ Time Frame: During the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Maintenance of clinical remission [ Time Frame: 2 weeks after the end of the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Maintenance of clinical remission [ Time Frame: 12 weeks after the end of the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment failures [ Time Frame: During the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Definition of therapeutic dose to be used in subsequent phase III trials. [ Time Frame: After statistical analysis of the results ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 410
Study Start Date: September 2007
Study Completion Date: October 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: GRACE

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528073

  Show 57 Study Locations
Sponsors and Collaborators
Alfa Wassermann 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Pier Alessandro Monici Preti MD, Alfa Wassermann S.p.A.
ClinicalTrials.gov Identifier: NCT00528073     History of Changes
Other Study ID Numbers: RETIC/03/06, EudraCT: 2007-001014-17
Study First Received: September 10, 2007
Last Updated: February 19, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation

Keywords provided by Alfa Wassermann S.p.A.:
Rifaximin-EIR
Crohn's disease
remission

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 29, 2014