Status:
COMPLETED
Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease
Lead Sponsor:
Teva GTC
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is being undertaken to evaluate whether delayed-release medications, designed to begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more effective than standa...
Detailed Description
This pilot clinical study is designed to evaluate the efficacy and safety of oral administration of novel, delayed-release test formulations, for targeted delivery to the ileum in Crohn's Disease pati...
Eligibility Criteria
Inclusion
- Male or Female patients, aged 18-75 years with moderate Crohn's Disease (CDAI score \>=220 and \<=400 at screening), with or without adjunctive mesalamine treatment, 12 with involvement of the ileum and three without ileal involvement
- Definitive diagnosis of active inflammatory CD with fibrostenosing and/or fistulizing/perforating CD types ruled out based on clinical and radiological or endoscopic or pathological findings, within the previous 6 months
Exclusion
- Body weight below 42.5 kg
- Subjects who have received either methotrexate, cyclosporine or anti-TNFalpha (infliximab, Remicade), anti-integrin (namixilab) in the past 3 months
- Subjects who are taking allopurinol, sulfasalazine, valerian, warfarin and corticosteroids,including budesonide and prednisone within 28 days prior to and throughout the study
- Previous bowel resection, including prior colostomy, ileostomy or colectomy with ileorectal anastomosis
- Symptomatic stenosis or ileal strictures; x-ray evidence of fibrosed bowel
- Subjects with ulcerative colitis or short bowel syndrome
- Subjects who present with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon
- Subjects with fistulizing CD or isolated small bowel CD
- Subjects with evidence of other serious infectious, autoimmune, hepatic,nephritic or systemic disease or compromised organ function
- Subjects with a history of GI tract malignancy or IBD-associated malignant changes in the intestines
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00287170
Start Date
July 1 2006
End Date
December 1 2007
Last Update
July 8 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hadassah Medical Center
Jerusalem, Israel, 91120