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COMPLETED Phase 2

CP-461 for the Treatment of Crohn's Disease

NCT00042055 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG CP-461

Study Locations (10)

Alabama

  • Southern Drug Research — Birmingham

California

  • Community Clinical Trials — Orange

Florida

  • Florida Medical Research Institute, PA — Gainesville

Georgia

  • Atlanta Gastroenterology Associates — Atlanta

Illinois

  • University of Chicago Medical Center — Chicago

Indiana

  • Indianapolis Gastroenterology and Hepatology, Inc. — Indianapolis

Maryland

  • Digestive Disease Associates, PA — Columbia

New Jersey

  • Atlantic Gastroenterology Associates — Egg Harbor

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2002-07
Est. Completion 2003-09
Phase Phase 2

Sponsor

Astellas Pharma

51 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00042055

The ClinicalTrials.gov registry entry for NCT00042055 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention — of which CP-461 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00042055 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00042055 about?

NCT00042055 is a clinical study titled "CP-461 for the Treatment of 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 mo...

What is the current status of trial NCT00042055?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2002-07. Estimated completion is 2003-09.

What conditions does trial NCT00042055 study?

This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00042055?

The interventions under investigation include: CP-461 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00042055?

This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00042055 being conducted?

This trial has 10 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial