Chondroitin Sulfate for Crohn's Disease
This study has been withdrawn prior to enrollment.
(Sponsor withdrew support after no patients enrolled)
Information provided by (Responsible Party):
Jeffry A. Katz, University Hospital Case Medical Center
First received: November 19, 2010
Last updated: August 29, 2012
Last verified: August 2012
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 cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.
Drug: chondroitin sulfate
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
Primary Outcome Measures:
- Biologic effect on inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
Experimental: chondroitin sulfate
400 mg (one table) TID
Drug: chondroitin sulfate
400 mg orally three times daily for 8 weeks
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245088
|University Hospitals Case medical Center
|Cleveland, Ohio, United States, 44106 |
University Hospital Case Medical Center
No publications provided
||Jeffry A. Katz, Associate Professor of Medicine, University Hospital Case Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 19, 2010
||August 29, 2012
||United States: Food and Drug Administration
Keywords provided by University Hospital Case Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Inflammatory Bowel Diseases
Digestive System Diseases