Chondroitin Sulfate for Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245088
Recruitment Status : Withdrawn (Sponsor withdrew support after no patients enrolled)
First Posted : November 22, 2010
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):
Jeffry A. Katz, University Hospitals Cleveland Medical Center

November 19, 2010
November 22, 2010
August 31, 2012
January 2011
March 2012   (Final data collection date for primary outcome measure)
Biologic effect on inflammation [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01245088 on Archive Site
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Chondroitin Sulfate for Crohn's Disease
A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
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.
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Crohn's Disease
Drug: chondroitin sulfate
400 mg orally three times daily for 8 weeks
Experimental: chondroitin sulfate
400 mg (one table) TID
Intervention: Drug: chondroitin sulfate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
March 2012   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Jeffry A. Katz, University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
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University Hospitals Cleveland Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP