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Chondroitin Sulfate for Crohn's Disease

NCT ID: NCT01245088

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Keywords

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Crohn's disease chondroitin sulfate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chondroitin sulfate

400 mg (one table) TID

Group Type EXPERIMENTAL

chondroitin sulfate

Intervention Type DRUG

400 mg orally three times daily for 8 weeks

Interventions

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chondroitin sulfate

400 mg orally three times daily for 8 weeks

Intervention Type DRUG

Eligibility 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffry A. Katz

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospitals Case medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CSCDZ

Identifier Type: -

Identifier Source: org_study_id