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

September 10, 2007
February 19, 2010
September 2007
March 2009   (final data collection date for primary outcome measure)
Clinical remission (Crohn's Disease Activity Index < 150 points) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Clinical remission (Crohn's Disease Activity Index < 150 points) [ Time Frame: After 12 weeks of treatment ]
Complete list of historical versions of study NCT00528073 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical response (reduction of baseline CDAI score by 100 points or more) [ Time Frame: Any time during the 12 weeks of treament ]
  • Clinical response (reduction of baseline CDAI by 70 points or more) [ Time Frame: At any time during the 12 weeks of treatment ]
  • Time to obtain clinical response and remission [ Time Frame: During the 12 weeks of treatment ]
  • Maintenance of clinical remission [ Time Frame: 2 weeks after the end of the 12 weeks of treatment ]
  • Maintenance of clinical remission [ Time Frame: 12 weeks after the end of the 12 weeks of treatment ]
  • Number of treatment failures [ Time Frame: During the 12 weeks of treatment ]
  • Definition of therapeutic dose to be used in subsequent phase III trials.
Not Provided
Not Provided
 
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
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: A
    Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid
    Intervention: Drug: Rifaximin-EIR
  • Experimental: B
    Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid
    Intervention: Drug: Rifaximin-EIR
  • Experimental: C
    Rifaximin-EIR tablet 3x400 mg bid
    Intervention: Drug: Rifaximin-EIR
  • Placebo Comparator: D
    Placebo 3 tablets bid
    Intervention: Drug: Rifaximin-EIR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
October 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary,   Israel,   Italy,   Poland,   Russian Federation
 
NCT00528073
RETIC/03/06, EudraCT: 2007-001014-17
Yes
Dr Pier Alessandro Monici Preti MD, Alfa Wassermann S.p.A.
Alfa Wassermann S.p.A.
Not Provided
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
Alfa Wassermann S.p.A.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP