Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
Condition: Inflammatory Bowel Disease; Intestinal Fistula
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Intestinal Fistula; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of the experimental
      drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have
      fistulas. The study will test whether or not patients receiving AST-120 experience a greater
      reduction in number of draining fistulas and improvement of their other Crohn's disease
      symptoms versus patients who receive placebo (material that does not contain any active
      medication).
    

Detailed description: 
      The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g
      sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres,
      Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil
      pouches). Both AST-120 and placebo are oral (taken by mouth)preparations. Both are tasteless.
      To take the product, patients will tear open the sachets, drop the contents directly on their
      tongue and wash it down with 8 ounces of water.

      Patients will be randomly assigned (like the toss of a coin), to receive either AST-120 or
      placebo. Patients will have a 50/50 chance of receiving placebo. Patients who participate in
      this study will be required to take a single dose of study drug (AST-120 or placebo) 3 times
      a day, 30 minutes after a meal, for 8 weeks, and be evaluated at Week 4 and Week 8. This is a
      'blinded' treatment, which means that neither the patient nor the study doctor will know if
      the patient has received study drug or placebo.

      If, at the end of the first full course of randomized treatment, (8 weeks), patients are not
      showing an improvement in their condition, they may have the option to receive the alternate
      blinded treatment for one treatment course (8 weeks). The study doctor will discuss this
      option with each patient individually. During this second course of treatment, patients will
      be evaluated at Week 12 and Week 16. If the patient does not respond to the alternate blinded
      treatment, or their condition worsens after 4 weeks (assessed at Week 12), they may be
      removed from the study at the discretion of the investigator.

      If patients respond to either the initial treatment or the alternate blinded treatment, they
      will have monthly doctor/clinic visits for up to 6 months (Week 24), or until their condition
      worsens or they relapse. Patients will not receive any study drug during this follow-up
      period.

      Relapse is defined for this study as:

        -  an increase by 1 or more in the number of draining fistulas for 2 sequential visits
           versus the number present at the time of response (response is defined as at least a 50%
           reduction in the number of draining fistulas at either Week 8, or for those patients
           receiving alternate blinded treatment, Week 16).

      There are a maximum of 8 patient evaluation visits in this study (Screen, Baseline, Week 4,
      Week 8, Week 12, Week 16, Week 20 and Week 24). Evaluations at most of these visits include a
      review of concomitant medications, medical history/adverse events, physical exam, fistula
      exam, blood draws for safety labs, urine pregnancy tests for females, and measurement of body
      weight. Patients will also be asked to keep a daily diary to record frequency of bowel
      movements, general well-being, and use of antidiarrheal medication.

      Treatment failure in this study is defined by one or more of the following occurring prior to
      Week 8:

        -  The need for additional therapies or dose increase for treatment of Crohn's disease,
           including an increase of corticosteroid dose to higher than baseline

        -  Clinical/symptomatic development of an abscess

        -  Clinical/symptomatic evidence of stricture

        -  The need for surgical intervention for Crohn's disease

        -  The patient withdraws from the study

      Patients will be discontinued from the study at any time if one or more of the following
      complications occur:

        -  Development of an abscess or symptomatic stricture

        -  The need for surgical intervention for Crohn's disease

        -  Occurrence of any other event that in the opinion of the investigator warrants
           discontinuation of the patient from the study

      In addition, patients whose CDAI score has risen by > or = 70 points above baseline or risen
      above 400 will be discontinued from the study.

      Administration of any additional therapies or dose increases of concomitant medications
      (including corticosteroids) to control Crohn's disease to higher than baseline while
      receiving study drug (initial randomized treatment or alternate blinded treatment) will
      require discontinuation of the patient from the study.

      Discontinued patients will be evaluated in a termination visit to document the lack of
      treatment efficacy and no further study treatment will be given.
    

Intervention name(s): AST-120
Intervention type(s): Drug
Intervention description(s): oral, sachet, 2 grams three times daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's disease; IBD; Inflammatory Bowel Disease; Fistula