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Chondroitin Sulfate for Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chondroitin sulfate
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, chondroitin sulfate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Case medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chondroitin sulfate

Arm Description

400 mg (one table) TID

Outcomes

Primary Outcome Measures

Biologic effect on inflammation

Secondary Outcome Measures

Full Information

First Posted
November 19, 2010
Last Updated
August 29, 2012
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01245088
Brief Title
Chondroitin Sulfate for Crohn's Disease
Official Title
A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor withdrew support after no patients enrolled
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, chondroitin sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chondroitin sulfate
Arm Type
Experimental
Arm Description
400 mg (one table) TID
Intervention Type
Drug
Intervention Name(s)
chondroitin sulfate
Intervention Description
400 mg orally three times daily for 8 weeks
Primary Outcome Measure Information:
Title
Biologic effect on inflammation
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Hospitals Case medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Chondroitin Sulfate for Crohn's Disease

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