CP-461 for the Treatment of Crohn's Disease

NCT00042055 | Completed Phase 2

• 1 other identifier: OSI-461-012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

Patients with moderately to severely active Crohn's disease will be treated with oral CP-461 200 mg (2 x 100 mg capsules) twice-daily for 8 weeks. The purpose of this study is to see if CP-461 improves the symptoms of Crohn's disease and/or the patient's quality of life. Patient's safety will be monitored throughout the study.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Inflammatory Bowel Disease

Interventions

CP-461 DRUG

Eligibility Criteria

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

You may qualify if:

• Men and women \> or = 18 years of age.
• Crohn's Disease Activity Index (CDAI) of \> or = 220 and \< or = 400.
• Crohn's disease of at least 3 months duration with colitis, ileitis, or ileocolitis, confirmed by radiography or endoscopy.
• Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization).
• Concomitant medications:
• If using aminosalicylates, the patient must have been using the aminosalicylates for at least 2 months before pre-screening. The dose must be stable for at least 2 weeks before pre-screening. If aminosalicylates are to be discontinued, it must be done at least 2 weeks before pre-screening.
• If using oral corticosteroids, the patient must have been receiving them for at least 2 months and must be on a stable dosage (\< or = 40 mg/day prednisone equivalent) for at least 2 weeks before pre-screening.
• If using infliximab, the patient must not have received an infliximab infusion for at least 12 weeks.
• If using azathioprine, 6-mercaptopurine (6-MP), or mycophenolate mofetil, the start date must be at least 3 months prior to pre-screening and the dose must be stable for at least 8 weeks before pre-screening.
• If using methotrexate, the patient must have been using methotrexate for at least 4 months before pre-screening with a stable dosage of at least 6 weeks.
• If using Crohn's disease-specific antibiotics, the patient must have been using them for at least 2 weeks at a stable dosage.
• The screening laboratory tests must meet the following criteria:
• Hemoglobin \> or = 8.5
• WBC \> or = 3.5 x 10 9/L
• Neutrophils \> or = 1.5 x 10 9/L

You may not qualify if:

• Local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated. Conditions that might preclude utilization of CDAI to assess response to therapy (such as "short gut" syndrome). If abscess is present, it should be drained before pre-screening, with at least 3 weeks between drainage of the abscess and pre-screening.
• Positive stool culture for enteric pathogens, pathogenic ova or parasites or Clostridium difficile toxin.
• Pregnancy, nursing, or unwillingness to comply with birth control.
• Patients who are currently receiving or have been treated with cyclosporine, tacrolimus, or sirolimus within 4 weeks of pre-screening.
• Infliximab infusion within 12 weeks of pre-screening.
• Rectally administered steroids within 2 weeks of pre-screening.
• Treatment with parenteral nutrition (TPN) within 3 weeks of prescreening.
• Signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
• Presence of a transplanted organ.
• Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
• Known substance abuse (drug or alcohol) during the last two years.
• Patients with a fever \> or = 100.5 degrees F.
• The patient is unable to return for follow-up evaluation.
• The patient has received an investigational drug or device within 30 days before the initiation of therapy.
• Refusal to sign the informed consent.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Cell Pathways: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (10)

Southern Drug Research

Birmingham, Alabama, 35211, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

Florida Medical Research Institute, PA

Gainesville, Florida, 32607, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indianapolis Gastroenterology and Hepatology, Inc.

Indianapolis, Indiana, 46237, United States

Location

Digestive Disease Associates, PA

Columbia, Maryland, 21044, United States

Location

Atlantic Gastroenterology Associates

Egg Harbor, New Jersey, 08234, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, 95219, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

(5-fluoro-2-methyl-1-(4-pyridyl)methylene-3-(N-benzyl)-indene)-acetamide hydrochloride

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2002
• First Posted: July 24, 2002
• Study Start: July 1, 2002
• Study Completion: September 1, 2003
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

US (10)