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CP-461 for the Treatment of Crohn's Disease

This study has been completed.
Sponsor:
Collaborators:
Cell Pathways
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00042055
First received: July 22, 2002
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: CP-461
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of CP-461 in the Treatment of Moderately to Severely Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 30
Study Start Date: July 2002
Study Completion Date: September 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • Platelets > or = 100 x 10 9/L
    • Serum creatinine less than 2.2 mg/dL.
    • Transaminases (AST/ALT) must be < or = 1.5 times the upper limit of normal range for the laboratory conducting the test.
    • Bilirubin must be WNL.
  • Patient must be able to adhere to the study visit schedule and other protocol requirements.
  • The patient must be capable of giving informed consent and the consent must be obtained before any study specific screening procedures.

Exclusion Criteria:

  • 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.
  • The patient is, in the opinions of the investigators, not an appropriate candidate for the study.
  • The following laboratory abnormalities:

    • Hemoglobin < 8.5
    • WBC < 3.5 x 10 9/L
    • Neutrophils < 1.5 x 10 9/L
    • Platelets < 100 x 10 9/L
    • Serum creatinine > or = 2.2 mg/dL
    • Transaminases (AST/ALT) > 1.5 times the upper limit of normal range for the laboratory conducting the test.
    • Bilirubin > upper limit of normal range for the laboratory conducting the test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042055

Locations
United States, Alabama
Southern Drug Research
Birmingham, Alabama, United States, 35211
United States, California
Community Clinical Trials
Orange, California, United States, 92868
United States, Florida
Florida Medical Research Institute, PA
Gainesville, Florida, United States, 32607
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis Gastroenterology and Hepatology, Inc.
Indianapolis, Indiana, United States, 46237
United States, Maryland
Digestive Disease Associates, PA
Columbia, Maryland, United States, 21044
United States, New Jersey
Atlantic Gastroenterology Associates
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
United States, Ohio
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, United States, 95219
Sponsors and Collaborators
Astellas Pharma Inc
Cell Pathways
OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00042055     History of Changes
Other Study ID Numbers: OSI-461-012
Study First Received: July 22, 2002
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Crohn's Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014