Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease

NCT00287170 | Completed Phase 1

• 1 other identifier: C2/13/6MP:CAL-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being undertaken to evaluate whether delayed-release medications, designed to begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more effective than standard systemically delivered drugs to promote remission or response in CD patients. It is hypothesized that the delayed-release medications will go right to the injured tissue and heal the disease more quickly. The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol (at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in the body that is derived from Vitamin D. There is much medical evidence that shows that lack of Vitamin D can be a possible risk factor in developing autoimmune disorders, including Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the symptoms of Crohn's Disease.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Local Ileal Delivery; Delayed-Release Formulations; 6-Mercaptopurine; Calcitriol

Outcome Measures

Primary Outcomes (2)

• Remission-defined as a CDAI (Crohn's Disease Activity Index) of <150

  12 weeks

• Response- defined as a fall in the CDAI by 100 points or more from baseline

  12 weeks

Secondary Outcomes (1)

• Improvement in ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein) levels, and IBDQ (Inflammatory Bowel Disease Questionnaire) >=180 indicative of remission

Interventions

Delayed Release 6MP or Calcitriol vs. Purinethol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female patients, aged 18-75 years with moderate Crohn's Disease (CDAI score \>=220 and \<=400 at screening), with or without adjunctive mesalamine treatment, 12 with involvement of the ileum and three without ileal involvement
• Definitive diagnosis of active inflammatory CD with fibrostenosing and/or fistulizing/perforating CD types ruled out based on clinical and radiological or endoscopic or pathological findings, within the previous 6 months

You may not qualify if:

• Body weight below 42.5 kg
• Subjects who have received either methotrexate, cyclosporine or anti-TNFalpha (infliximab, Remicade), anti-integrin (namixilab) in the past 3 months
• Subjects who are taking allopurinol, sulfasalazine, valerian, warfarin and corticosteroids,including budesonide and prednisone within 28 days prior to and throughout the study
• Previous bowel resection, including prior colostomy, ileostomy or colectomy with ileorectal anastomosis
• Symptomatic stenosis or ileal strictures; x-ray evidence of fibrosed bowel
• Subjects with ulcerative colitis or short bowel syndrome
• Subjects who present with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon
• Subjects with fistulizing CD or isolated small bowel CD
• Subjects with evidence of other serious infectious, autoimmune, hepatic,nephritic or systemic disease or compromised organ function
• Subjects with a history of GI tract malignancy or IBD-associated malignant changes in the intestines

Sponsors & Collaborators

• Teva GTC: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yaron Ilan, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: July 1, 2006
• Study Completion: December 1, 2007
• Last Updated: July 8, 2008

Record last verified: 2008-07

Locations

IL (1)