Main
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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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01245088 |
Date of registration:
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19/11/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Chondroitin Sulfate for Crohn's Disease
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Scientific title:
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A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease |
Date of first enrolment:
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January 2011 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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http://clinicaltrials.gov/show/NCT01245088 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: chondroitin sulfate
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Primary Outcome(s)
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Biologic effect on inflammation
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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