Clinical Trial: Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

Brief 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 Summary:

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 unti
Sponsor: Ocera Therapeutics

Current Primary Outcome:

  • Efficacy: The proportion of patients considered to be "treatment successes" defined by a reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period [ Time Frame: 8 weeks ]
  • Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment [ Time Frame: 8 weeks ]


Original Primary Outcome:

  • Efficacy: A reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period
  • Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment


Current Secondary Outcome:

  • Efficacy: 100% non-draining fistulas at both week 4 and week 8 [ Time Frame: 8 weeks ]
  • Efficacy: Fistula response at Week 8 [ Time Frame: 8 weeks ]
  • Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment [ Time Frame: 8 weeks ]
  • Safety: Clinical laboratory tests (electrolytes) [ Time Frame: 8 weeks ]
  • Safety: Development of abscesses [ Time Frame: 8 weeks ]
  • Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 8 weeks ]


Original Secondary Outcome:

  • Efficacy: 100% non-draining fistulas at both week 4 and week 8
  • Absolute numbers of draining fistulas at week 4 and week 8
  • Change in CDAI scores from baseline at week 4 and week 8
  • Change in PDAI scores from baseline at week 4 and week 8
  • Time to relapse from success at week 8
  • Average frequency of liquid bowel movements during the first 8 weeks
  • Change in CRP levels from baseline at week 4 and week 8
  • Treatment failure due to the need for a change in drug therapy to treat mild to moderately active Crohn's disease at week 4 and week 8
  • Safety: Clinical laboratory tests (electrolytes)
  • Development of abscesses
  • Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature)
  • Prior and concomitant medications


Information By: Ocera Therapeutics

Dates:
Date Received: May 1, 2006
Date Started: March 2006
Date Completion:
Last Updated: May 27, 2014
Last Verified: May 2014