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This study has been withdrawn prior to enrollment.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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245088

Locations
United States, Ohio
University Hospitals Case medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
  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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014