Chondroitin Sulfate for Crohn's Disease

This study has been withdrawn prior to enrollment.
(Sponsor withdrew support after no patients enrolled)
Sponsor:
Information provided by (Responsible Party):
Jeffry A. Katz, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01245088
First received: November 19, 2010
Last updated: August 29, 2012
Last verified: August 2012

November 19, 2010
August 29, 2012
January 2011
March 2012   (final data collection date for primary outcome measure)
Biologic effect on inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01245088 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01245088
CSCDZ
No
Jeffry A. Katz, University Hospital Case Medical Center
University Hospital Case Medical Center
Not Provided
Not Provided
University Hospital Case Medical Center
August 2012

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