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Completed Phase 2 Interventional Results available

A Study To Monitor Long-Term Treatment With PF-00547659

ClinicalTrials.gov ID: NCT01298492

Public ClinicalTrials.gov record NCT01298492. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01298492
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Shire
Industry
Enrollment
268 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2011
Primary completion
Jul 26, 2016
Completion
Jul 26, 2016
Last update posted
Jun 2, 2021

2011 – 2016

United States locations

U.S. sites
47
U.S. states
13
U.S. cities
24
Facility City State ZIP Site status
UCSD Medical Center - Thorton Hospital La Jolla California 92037
Community Clinical Trials Orange California 92868
GastroDiagnostics Orange California 92868
Clinical Research of the Rockies Lafayette Colorado 80026
Rmga - Rmcr Thornton Colorado 80229
Rocky Mountain Gastroenterology Associates Thornton Colorado 80229
MGG Group Co., Inc. Washington D.C. District of Columbia 20006
Florida Center for Gastroenterology Largo Florida 33777
Sylvester Comprehensive Cancer Center Miami Florida 33136
University of Miami Crohn's and Colitis Center Miami Florida 33136
University of Miami Hospital and Clinic (IP Shipment Only) Miami Florida 33136
University of Miami Hospital and Clinic Miami Florida 33136
University of Miami Hospital Miami Florida 33136
Citrus Ambulatory Surgery Center Orlando Florida 32806
Internal Medicine Specialists Orlando Florida 32806
Heartland Medical Research, Inc. Clive Iowa 50325
Iowa Digestive Disease Center Clive Iowa 50325
Iowa Endoscopy Center (Colonoscopy Only) Clive Iowa 50325
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research Chevy Chase Maryland 20815
UMass Memorial Medical Center Worcester Massachusetts 01655
University of Massachusetts Worcester Worcester Massachusetts 01655
Center for Digestive Health Troy Michigan 48098
Surgical Centers of Michigan Troy Michigan 48098
Surgery Center of Columbia Columbia Missouri 65201
Audrain Medical Center Mexico Missouri 65265
Center for Digestive and Liver Diseases, Inc. Mexico Missouri 65265
Barnes-Jewish Hospital - Investigational Drug Services St Louis Missouri 63108
Barnes-Jewish Hospital St Louis Missouri 63110
Center for Advanced Medicine St Louis Missouri 63110
Washington University School of Medicine St Louis Missouri 63110
Albany Medical College Albany New York 12208
New York Hospital Queens Flushing New York 11355
Long Island Clinical Research Associates, LLP Great Neck New York 11021
Nassau Gastroenterology Associates Office Based Surgery Great Neck New York 11021
Nassau Gastroenterology Associates, P.C. Great Neck New York 11021
North Shore Primary Care, P.C. Great Neck New York 11021
Lenox Hill Endoscopy Center New York New York 10075
Synergy First New York New York 11230
Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York 12601
CTRC Hospital, UNC Memorial Hospital Chapel Hill North Carolina 27514
North Carolina Memorial Hospital Endoscopy Center Chapel Hill North Carolina 27514
UNC Hospitals Chapel Hill North Carolina 27514
UNC Hospitals Endoscopy Chapel Hill North Carolina 27517
Hillsborough Campus Hillsborough North Carolina 27278
University of Washington Medical Center Seattle Washington 98195
University of Washington Seattle Washington 98195
Allegiance Research Specialists Wauwatosa Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01298492, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 2, 2021 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01298492 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →