Chondroitin Sulfate for Crohn's Disease

Phase 1

Withdrawn

• Conditions: Crohn's Disease
• Interventions: Drug: chondroitin sulfate

• Registration Number: NCT01245088
• Lead Sponsor: University Hospitals Cleveland Medical Center

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 cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Study Start: 2011-01
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-29
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

  2. Age > 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment.

  3. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment.

  4. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment.

  5. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment.

  6. 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.

  3. 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.

  4. Patients who are pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chondroitin sulfate	chondroitin sulfate	400 mg (one table) TID

Primary Outcome Measures

Name	Time	Method
Biologic effect on inflammation	8 weeks

Trial Locations

Locations (1)

University Hospitals Case medical Center; 🇺🇸 Cleveland, Ohio, United States