Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Phase 3
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Pain, Cancer
Both
Pain, Cancer
Trial Information
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
The objective of this study is to determine the tolerability and safety of OraVescent
fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer
patients.
Inclusion Criteria:
- 18-80 years of age
- Average of 1-4 breakthrough pain episodes per day
- Opioid tolerant
- Histologically documented diagnosis of a malignant solid tumor or hematological
malignancy
Exclusion Criteria:
- Primary breakthrough pain is not related to cancer in any way
- Opioid or fentanyl intolerance
- Chronic obstructive pulmonary disease (COPD) or heart disease
- Sleep apnea or active brain metastases with increased cranial pressure
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tolerability and safety of OraVescent fentanyl when used long-term
Authority:
United States: Food and Drug Administration
Study ID:
099-15
NCT ID:
NCT00105937
Start Date:
April 2004
Completion Date:
November 2006
Related Keywords:
- Pain
- Cancer
- Cancer
- Pain
Name | Location |
|---|---|
| Beth Israel Medical Center | New York, New York 10003 |
| North Shore University Hospital | Manhasset, New York 11030 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| Hematology Oncology Associates | Atlantis, Florida 33462 |
| Saint Joseph's Mercy Cancer Center | Hot Springs, Arkansas 71913 |
| Arizona Clinical Research Center | Tucson, Arizona 85712 |
| St. Agnes Healthcare | Baltimore, Maryland 21229 |
| Innovative Medical Research of South Florida | Miami Shores, Florida 33138 |
| Outcomes Research International | Tucson, Arizona 85711 |
| Hematology and Oncology Specialists | New Orleans, Louisiana 70115 |
| Southwest Oncology Associates | Lafayette, Louisiana 70503 |
| Providence Cancer Institute | Southfield, Michigan 48075 |
| Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
| Florida Medical Clinic, PA | Zephyrhills, Florida 33542 |
| Center for Pain Management | Huntsville, Alabama 35801 |
| Florida Institute of Medical Research | Jacksonville, Florida 32207 |
| PETC Research Group, Inc. | Tulsa, Oklahoma 74137 |
| North Shore Cancer Research Association | Skokie, Illinois 60076 |
| University of Wisconsin Medical School | Madison, Wisconsin 53792-0001 |
| Hot Spring Pain Clinic | Hot Springs, Arkansas 71913 |
| Arkansas Cancer Institute | Pine Bluff, Arkansas 71603 |
| The Cancer Prevention and Treatment Center | Soquel, California 95073 |
| Northwestern Connecticut Oncology & Hematology Associates | Torrington, Connecticut 06790 |
| University of Florida Shands Cancer Center at Jacksonville | Jacksonville, Florida 32209 |
| Gulf Coast Oncology Association | St. Petersburg, Florida 33705 |
| Clinical Pharmacology Services, Inc | Tampa, Florida 33617 |
| Palm Beach Research | West Palm Beach, Florida 33409 |
| Southeastern Gynecologic Oncology, LLC | Atlanta, Georgia 30342 |
| Huron Medical Center | Port Huron, Michigan 48067 |
| Bond Clinic, Inc | Rolla, Missouri 65407 |
| HealthCare Research, LLC | St. Louis, Missouri 63141 |
| The Center for Clinical Research, LLC | Winston-Salem, North Carolina 27103 |
| Oncology Associates of Oregon | Eugene, Oregon 97401 |
| Allegheny Pain Management, PC | Altoona, Pennsylvania 16601 |
| St. Mary Medical Center | Langhorne, Pennsylvania 19047 |
| Mohamed Haq | Pasadena, Texas 77504 |
| Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
| UTHCT (ATTN: Clinical Research) | Tyler, Texas 75708 |
| Hunstman Cancer Institute | Salt Lake City, Utah 84112 |
| Palliative Care and Pain Medicine | Salt Lake City, Utah 84157 |
| Great Basin Clinical Research | West Point, Utah 84015 |
| Cancer Outreach Associates, PC | Abingdon, Virginia 24211 |
| MedSource Inc | Richmond, Virginia 23229 |
