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NCT01298492 · ClinicalTrials.gov registry record · Phase 2
A Study To Monitor Long-Term Treatment With PF-00547659
A Phase 2 study of Crohn's Disease, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 268
- Enrollment target
- 20
- Study locations
NCT01298492: Completed Phase 2 study of Crohn's Disease, sponsored by Shire.
NCT01298492 is a Phase 2 study of Crohn's Disease that has completed, run by Shire. The registered enrollment target is 268 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01298492, a Phase 2 study of Crohn's Disease, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 268 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
Primary Outcome
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial
Conditions Studied
Interventions
- DRUG PF-00547659
Study Locations (20)
Florida
- Florida Center for Gastroenterology - Largo
- Sylvester Comprehensive Cancer Center - Miami
- University of Miami Crohn's and Colitis Center - Miami
- University of Miami Hospital and Clinic (IP Shipment Only) - Miami
- University of Miami Hospital and Clinic - Miami
- University of Miami Hospital - Miami
- Citrus Ambulatory Surgery Center - Orlando
- Internal Medicine Specialists - Orlando
California
- UCSD Medical Center - Thorton Hospital - La Jolla
- Community Clinical Trials - Orange
- GastroDiagnostics - Orange
Colorado
- Clinical Research of the Rockies - Lafayette
- Rmga - Rmcr - Thornton
- Rocky Mountain Gastroenterology Associates - Thornton
Iowa
- Heartland Medical Research, Inc. - Clive
- Iowa Digestive Disease Center - Clive
- Iowa Endoscopy Center (Colonoscopy Only) - Clive
District of Columbia
- MGG Group Co., Inc. - Washington D.C.
Maryland
- Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research - Chevy Chase
Massachusetts
- UMass Memorial Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2016-07-27 |
| Phase | Phase 2 |
What the finished NCT01298492 record still lists
NCT01298492 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which PF-00547659 is the first listed.
NCT01298492 names 20 study sites across 7 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01298492 about?
NCT01298492 is a clinical study titled "A Study To Monitor Long-Term Treatment With PF-00547659". This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
What is the current status of trial NCT01298492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 268 participants. The study started on 2011-07-01. Estimated completion is 2016-07-27.
What conditions does trial NCT01298492 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT01298492?
The interventions under investigation include: PF-00547659 (DRUG).
Who is sponsoring clinical trial NCT01298492?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01298492 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01298492's enrollment target sits among peer trials
268 44th of 105 higher than 61 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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