A 4-week Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Pain
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5
The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.
Day 0 (baseline), approximately week 5
No
United States: Food and Drug Administration
C25608/3054/BP/US
NCT00387010
December 2006
October 2007
Name | Location |
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Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Pain Consultants of Oregon | Eugene, Oregon 97401 |
Altoona Center for Clinical Research | Duncansville, Pennsylvania 16635 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Lifetree Clinical Research | Salt Lake City, Utah 84106 |
Allegheny Pain Management, PC | Altoona, Pennsylvania 16601 |
Arizona Research Center | Phoenix, Arizona 85023 |
Clinical Research Center of Nevada | Las Vegas, Nevada 89104 |
Birmingham Pain Center | Birmingham, Alabama 35244 |
Orange County Clinical Trials | Anaheim, California 92801 |
Vertex Clinical Research | Bakersfield, California 93311 |
Lovelace Scientific Resources, Inc. | Beverly Hills, California 90211 |
Synergy Clinical Research Center | National City, California 91950 |
Pain Institute of Santa Monica | Santa Monica, California 90404 |
Integrative Pain Manage Centers | Westminster, Colorado 80021 |
Advanced Diagnostic Pain Treatment Center | New Haven, Connecticut 06511 |
Alliance Medical Research Group | Clearwater, Florida 33761 |
Innovative Research of West Florida | Largo, Florida 33770 |
Lovelace Scientific Resources, Inc. | Sarasota, Florida 34233 |
Stedman Clinical Trials | Tampa, Florida 33647 |
Dawsonville Family Medicine | Dawsonville, Georgia 30534 |
Millennium Pain Center | Bloomington, Illinois 61701 |
Pain and Rehabilitation Clinic of Chicago | Chicago, Illinois 60610 |
Rehabilitation Associates of Indiana | Indianapolis, Indiana 46250 |
Northwest Indiana Center for Clinical Research, PC | Valparaiso, Indiana 46383 |
ICRI, Inc. | Overland Park, Kansas 66211 |
Willis-Knighton Pain Management Center | Shreveport, Louisiana 71103 |
Lovelace Scientific Resources Center | Henderson, Nevada 89014 |
SUNY - Stonybrook | Stony Brook, New York 11794 |
DeGarmo Institute of Medical Research | Greer, South Carolina 29651 |
Comprehensive Pain Specialists, PLLC | Hendersonville, Tennessee 37075 |
KRK Medical Research | Richardson, Texas 75080 |
BeXar Clinical Trials, LLC | Richardson, Texas 75082 |