inflamattory bowel dissease
Conditions
Interventions
3 times per day 2g AST-120 or placebo
Sponsors
Ocera Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -18 to 70 years of age -Body Weight: (>=40 kg) -Documented diagnosis of Crohn*s disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis -Presence of at least one draining perianal fistula. Patients with enterocutaneous fistula can be included if they have >= 1 draining perianal fistula. Women with rectovaginal fistulas are included if they have >= 1 draining perianal fistula. -Crohn*s Disease Activity Index (CDAI) score = 100,000/µL -Able and willing to comply with all protocol procedures
Exclusion criteria
Exclusion criteria: Patients previously treated with infliximab for fistulas caused by Crohn*s disease and who did not respond to infliximab therapyInfliximab therapy within 3 months prior to enrollment in the studyPresence of symptomatic strictures or suggestion of significant clinical obstructionPatients with setons; unless setons are removed within 48 hours prior to study entryPresence of entero-entero, recto-vesicular, entero-vesicular fistulas§ The patient is unable to stay on a stable dose of concomitant Crohn*s disease medication(s) for at least 10 weeks in the opinion of the investigator§ Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn*s disease (e.g. bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)§ Severe diarrhea defined by > 10 liquid bowel movements per day§ Other local manifestations of mild to moderately active Crohn*s disease such as abscesses, or other disease manifestations for which surgery might be indicated, or which might preclude utilization of a CDAI to assess response to therapy (e.g. short bowel syndrome)§ Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen§ Hemoglobin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is treatment success in the therapy for mild to moderate Crohn*s disease with fisultas defined by: - A reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| - 100% non-draining fistulas at both week 4 and week 8 (complete response)- 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 needed to treat mild to moderately active Crohn*s disease at week 4 and week 8 | — |
Countries
Netherlands
Outcome results
None listed