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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01245088
Date of registration: 19/11/2010
Prospective Registration: Yes
Primary sponsor: University Hospital Case Medical Center
Public title: Chondroitin Sulfate for Crohn's Disease
Scientific title: A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
Date of first enrolment: January 2011
Target sample size: 0
Recruitment status: Withdrawn
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Key inclusion & exclusion 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

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

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.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: chondroitin sulfate
Primary Outcome(s)
Biologic effect on inflammation [Time Frame: 8 weeks]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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