A double-blind, randomised, placebo-controlled multicenter study to asses the safety and efficacy of AST-120 in mild to moderately active Crohn's patients with fistulas.
- Conditions
- inflamattory bowel dissease10017969
- Registration Number
- NL-OMON30808
- Lead Sponsor
- Ocera Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
-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 < 400
-Platelet count (thrombocytes) >= 100,000/µL
-Able and willing to comply with all protocol procedures
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 < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen§ Women who are pregnant, breast feeding, or planning to become pregnant during the study§ Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months § Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient*s ability to complete the trial§ Uncontrolled systemic disease § Patients undergoing chemotherapy for the treatment of cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is treatment success in the therapy for mild to<br /><br>moderate Crohn*s disease with fisultas defined by: - A reduction of at least<br /><br>50% in the number of draining fistulas at both week 4 and week 8</p><br>
- Secondary Outcome Measures
Name Time Method <p>- 100% non-draining fistulas at both week 4 and week 8 (complete response)-<br /><br>Absolute numbers of draining fistulas at week 4 and week 8- Change in CDAI<br /><br>scores from baseline at week 4 and week 8- Change in PDAI scores from baseline<br /><br>at week 4 and week 8- Time to relapse from success at week 8- Average frequency<br /><br>of liquid bowel movements during the first 8 weeks- Change in CRP levels from<br /><br>baseline at week 4 and week 8- Treatment failure due to the need for a change<br /><br>in drug therapy needed to treat mild to moderately active Crohn*s disease at<br /><br>week 4 and week 8</p><br>