Multi-Center Study Evaluating 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 Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Inclusion Criteria:
- Documented diagnosis of a malignant solid tumor or hematological malignancy causing
cancer related pain
- Currently taking around the clock opioid therapy for pain
- Experience on average, 1-4 breakthrough pain episodes per day
Exclusion Criteria:
- Opioid or fentanyl intolerance
- Sleep apnea or active brain metastases with increased intracranial pressure
- COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
C25608/3039/BP/US
NCT ID:
NCT00105287
Start Date:
February 2004
Completion Date:
Related Keywords:
- Pain
- Cancer
- cancer
- pain
- Breakthrough Pain in cancer patients
Name | Location |
|---|---|
| Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
| Advanced Clinical Research Institute | Anaheim, California 92801 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Pacific Clinical Research | Santa Monica, California 90404 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Clinical Trials & Research Associates, Inc. | Montebello, California 90640 |
| Hematology Oncology Associates of Treasure Coast | Port St. Lucie, Florida 34952 |
| NYU Pain Management Center | New York, New York 10016 |
| Lifetree Clinical Research | Salt Lake City, Utah 84106 |
| Great Falls Clinic, LLP | Great Falls, Montana 59405 |
| Charleston Hematology Oncology, PA | Charleston, South Carolina 29403 |
| Pacific Cancer Medical Center | Anaheim, California 92801 |
| Cullman Oncology and Hematology | Cullman, Alabama 35058 |
| Compassionate Cancer Care Medical Group | Corona, California 92882 |
| Compassionate Cancer Center | Fountain Valley, California 92708 |
| San Diego Hospice & Palliative Care | San Diego, California 92103 |
| Lovelace Scientific Resources | Miami, Florida 33143 |
| Gulf Coast Pain Specialists | Pensacola, Florida 32503 |
| Center for Prospective Outcome | Marietta, Georgia 30060 |
| Iowa Pain Management Clinic, PC | Des Moines, Iowa 50265 |
| Donald Berdeaux | Great Falls, Montana 59405 |
| Southern Nevada Cancer Research | Las Vegas, Nevada 89106 |
| Research Across America | New York, New York 10021 |
| Brody School of Medicine | Greenville, North Carolina 27858 |
| University of Rochester | San Antonio, Texas 78229 |
| Cache Valley Cancer Treatment and Research Clinic, Inc. | West Point, Utah 84015 |
