Chondroitin Sulfate for Crohn's Disease

NCT01245088 | Withdrawn Phase 1

• 1 other identifier: CSCDZ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; chondroitin sulfate

Outcome Measures

Primary Outcomes (1)

• Biologic effect on inflammation

  8 weeks

Study Arms (1)

chondroitin sulfate

EXPERIMENTAL

400 mg (one table) TID

Drug: chondroitin sulfate

Interventions

chondroitin sulfate DRUG

400 mg orally three times daily for 8 weeks

chondroitin sulfate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Age \> 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment.
• \. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment.
• \. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment.
• \. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment.
• \. 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.

You may not qualify if:

• \. Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement.
• \. 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.
• \. 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.
• \. Patients who are pregnant.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Chondroitin Sulfates

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

US (1)