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Crohn's DiseasePhase 2NCT00042055

CP-461 for the Treatment of Crohn's Disease

A Phase 2 study testing CP-461 in people with Crohn's Disease, run by Astellas Pharma Inc at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
CP-461
How many people
30 participants
Where
10 sitesUnited States
Study dates
Jul 2002to Sep 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Southern Drug Research

    Birmingham, Alabama, 35211

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Consultants for Clinical Research, Inc.

    Cincinnati, Ohio, 95219

  • Digestive Disease Associates, PA

    Columbia, Maryland, 21044

  • Atlantic Gastroenterology Associates

    Egg Harbor, New Jersey, 08234

  • Florida Medical Research Institute, PA

    Gainesville, Florida, 32607

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Indianapolis Gastroenterology and Hepatology, Inc.

    Indianapolis, Indiana, 46237

  • Community Clinical Trials

    Orange, California, 92868

Other trials in United States

About this study

Official title: 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.

Conditions
Crohn's Disease
Being tested
CP-461
Keywords
Crohn's Disease, Inflammatory Bowel Disease
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-461Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2002 (estimated)
  2. Study startJul 2002
  3. Study completionSep 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042055
Sponsor's protocol ID
OSI-461-012
Status last verified
Oct 2011
First submitted
22 Jul 2002
Last updated
17 Oct 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-461 in people with Crohn's Disease, run by Astellas Pharma Inc at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00042055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.

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