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
- Conditions
- The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.
- Registration Number
- EUCTR2005-005363-28-BE
- Lead Sponsor
- Ocera Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
18 to 65 years of age
Body Weight: (=40 kg)
Documented diagnosis of Crohn’s disease, including patients with documentted diagnosis of ileitis, colitis, or ileocolitis
Presence of at least one draining fistula. Women with rectovaginal fistulas are included if they have = 1 other externally draining fistula.
Crohn’s Disease Activity Index (CDAI) score < 400
Platelet count (thrombocytes) =100,000/µL
Able and willing to comply with all protocol procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients previously treated with infliximab for fistulas cuased by Chrohn's disease and who did not experience 100% fistula closure in response to infliximab therapy.
Receiving infliximab therapy within 12 months prior to enrollment in the study
Presence of symptomatic strictures or suggestion of significant obstruction
Patients with setons; unless setons are removed at least 48 hours prior to study entry
Presence 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
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method