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NCT01620255 · ClinicalTrials.gov registry record · Phase 2
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT01620255: Completed Phase 2 study of Ulcerative Colitis, sponsored by Shire.
NCT01620255 is a Phase 2 study of Ulcerative Colitis that has completed, run by Shire. The registered enrollment target is 357 participants, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01620255, a Phase 2 study of Ulcerative Colitis, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Clinical remission was defined as a Total Mayo Score of less than or equal (\<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The ce
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 |
What the finished NCT01620255 record still lists
NCT01620255 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (83% lower).
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.
NCT01620255 names 20 study sites across 5 states, led by California, Connecticut, Florida.
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.
What interventions are being tested in trial NCT01620255?
The interventions under investigation include: Placebo (DRUG), PF-00547659 SC Injection (DRUG).
Who is sponsoring clinical trial NCT01620255?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01620255's enrollment target sits among peer trials
357 28th of 122 higher than 95 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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