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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This study has been withdrawn prior to enrollment.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 Identifier:
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.

Condition Intervention Phase
Crohn's Disease Drug: chondroitin sulfate Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease

Resource links provided by NLM:

Further study details as provided by Jeffry A. Katz, University Hospital Case Medical Center:

Primary Outcome Measures:
  • Biologic effect on inflammation [ Time Frame: 8 weeks ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01245088

United States, Ohio
University Hospitals Case medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Jeffry A. Katz, Associate Professor of Medicine, University Hospital Case Medical Center Identifier: NCT01245088     History of Changes
Other Study ID Numbers: CSCDZ
Study First Received: November 19, 2010
Last Updated: August 29, 2012

Keywords provided by Jeffry A. Katz, University Hospital Case Medical Center:
Crohn's disease
chondroitin sulfate

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on September 21, 2017