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A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
NCT01620255 · View on ClinicalTrials.gov ↗
Study Summary
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-00547659 SC Injection
Study Locations (20)
California
- UCSD Health System-Pharmacy only — La Jolla
- Clinical and Translational Research Institute — La Jolla
- Perlman Medical Offices — La Jolla
- Thornton Hospital — La Jolla
- Community Clinical Trials — Orange
- GastroDiagnostics - Community Clinical Trials Drug — Orange
Connecticut
- Endoscopy Center of Connecticut, LLC — Guilford
- Endoscopy Center of Connecticut, LLC — Hamden
- Gastroenterology Center of Connecticut, PC — Hamden
- Medical REsearch Center of CT Drug — Hamden
- Medical Research Network of Connecticut — Hamden
Florida
- Florida Surgery Center — Altamonte Springs
- Gastroenterology Associates — Crystal River
- Research Consultant Group — Hialeah
- Th Palmetto Surgery Center — Hialeah
- Citrus Memorial Hospital — Inverness
Colorado
- Rocky Mountain Clinical Research, LLC. — Denver
- Clinical Research of the Rockies — Lafayette
- Rocky Mountain Gastroenterology Associates — Thornton
Arizona
- Mayo Clinic Arizona — Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2012-11-02 |
| Est. Completion | 2016-02-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01620255
The ClinicalTrials.gov registry entry for NCT01620255 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 357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 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 Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT01620255 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Connecticut, 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 NCT01620255 about?
NCT01620255 is a clinical study titled "A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis". To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
What is the current status of trial NCT01620255?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 357 participants. The study started on 2012-11-02. Estimated completion is 2016-02-04.
What conditions does trial NCT01620255 study?
This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01620255?
The interventions under investigation include: Placebo (DRUG), PF-00547659 SC Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01620255?
This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01620255 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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