Status:
WITHDRAWN
Chondroitin Sulfate for Crohn's Disease
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed through serum and tissue...
Eligibility Criteria
Inclusion
- 1\. Colonic or ileocolonic CD diagnosed for at least 3 months. 2. Active CD, defined as a Crohn's Disease Activity Index (CDAI; Appendix A) \[Best 1976\] of greater than 200 but less than 320 at the time entry into the study.
- 3\. Age \> 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment.
- 5\. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment.
- 6\. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment.
- 7\. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment.
- 8\. Patient on biologic therapy with infliximab, adalimumab, or certolizumab must be on stable therapy for 12 weeks prior to enrollment 9. Patient must sign informed consent.
Exclusion
- 1\. Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement.
- 2\. Patients with known ulcerative colitis. 3. Patients expected to require surgery within 30 days for complications of CD. 4. Patients with CD and an intraabdominal abscess. 5. Patients requiring continuous antibiotics; antibiotics may be taken up to the point of enrollment into the study.
- 6\. Patients with severe cardiac, pulmonary, or renal disease. 7. Patients with a h/o malignancy other than resected basal cell carcinoma of the skin 8. Patients who have participated in another clinical research study in the past 8 weeks.
- 9\. Patients who are pregnant.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01245088
Start Date
January 1 2011
End Date
May 1 2012
Last Update
August 31 2012
Active Locations (1)
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1
University Hospitals Case medical Center
Cleveland, Ohio, United States, 44106