- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042055
CP-461 for the Treatment of Crohn's Disease
A Phase II Pilot Study of CP-461 in the Treatment of Moderately to Severely Active Crohn's Disease
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.
Study Overview
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35211
- Southern Drug Research
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California
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Orange, California, United States, 92868
- Community Clinical Trials
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Florida
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Gainesville, Florida, United States, 32607
- Florida Medical Research Institute, PA
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Georgia
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Atlanta, Georgia, United States, 30342
- Atlanta Gastroenterology Associates
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46237
- Indianapolis Gastroenterology and Hepatology, Inc.
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Maryland
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Columbia, Maryland, United States, 21044
- Digestive Disease Associates, PA
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New Jersey
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Egg Harbor Township, New Jersey, United States, 08234
- Atlantic Gastroenterology Associates
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New York
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Great Neck, New York, United States, 11021
- Long Island Clinical Research Associates, LLP
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Ohio
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Cincinnati, Ohio, United States, 95219
- Consultants For Clinical Research, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSI-461-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ProgenaBiomeRecruitingCrohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Crohn's | Crohn Disease of Ileum | Crohn Ileitis | Crohn's Disease Relapse | Crohns Disease Aggravated | Crohn Disease in Remission | Crohn's Disease of PylorusUnited States
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Massachusetts General HospitalAmerican College of GastroenterologyNot yet recruitingInflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's EsophagitisUnited States
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Richard Burt, MDTerminatedCROHN'S DISEASEUnited States
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Agomab Spain S.L.RecruitingFibrostenotic Crohn's DiseaseUnited States, Italy, Poland, Spain, Denmark, Austria, Canada, Germany
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AbbVieActive, not recruitingCrohn's Disease (CD)United States, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Slovakia, Spain, United Kingdom
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AbbVieActive, not recruitingCrohn's Disease (CD)United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, Slo... and more
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University Hospital, LilleMinistry of Health, FranceTerminatedCrohn's Disease AggravatedFrance
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TakedaRecruitingCrohn's Disease (CD)United States, Australia, Israel, Belgium, Hungary, Canada, China, Croatia, Czechia, Greece, Italy, Japan, Korea, Republic of, Poland, United Kingdom, Lithuania, Slovakia, Spain
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Weill Medical College of Cornell UniversityThe Kenneth Rainin FoundationRecruitingCrohn's Disease (CD)United States
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