Chondroitin Sulfate for Crohn's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: chondroitin sulfate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease |
- Biologic effect on inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: chondroitin sulfate
400 mg (one table) TID
|
Drug: chondroitin sulfate
400 mg orally three times daily for 8 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jeffry A. Katz, Associate Professor of Medicine, University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT01245088 History of Changes |
| Other Study ID Numbers: | CSCDZ |
| Study First Received: | November 19, 2010 |
| Last Updated: | August 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University Hospital Case Medical Center:
|
Crohn's disease chondroitin sulfate |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013