Pain Clinical Trial
Official title:
Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
| Verified date | May 2014 |
| Source | Teva Pharmaceutical Industries |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | September 2007 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | Advanced Clinical Research Institute | Anaheim | California |
| United States | Pacific Cancer Medical Center | Anaheim | California |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Charleston Hematology Oncology, PA | Charleston | South Carolina |
| United States | Compassionate Cancer Care Medical Group | Corona | California |
| United States | Cullman Oncology and Hematology | Cullman | Alabama |
| United States | Iowa Pain Management Clinic, PC | Des Moines | Iowa |
| United States | Compassionate Cancer Center | Fountain Valley | California |
| United States | Donald Berdeaux | Great Falls | Montana |
| United States | Great Falls Clinic, LLP | Great Falls | Montana |
| United States | Brody School of Medicine | Greenville | North Carolina |
| United States | Southern Nevada Cancer Research | Las Vegas | Nevada |
| United States | Center for Prospective Outcome | Marietta | Georgia |
| United States | Lovelace Scientific Resources | Miami | Florida |
| United States | Clinical Trials & Research Associates, Inc. | Montebello | California |
| United States | NYU Pain Management Center | New York | New York |
| United States | Research Across America | New York | New York |
| United States | Gulf Coast Pain Specialists | Pensacola | Florida |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Hematology Oncology Associates of Treasure Coast | Port St. Lucie | Florida |
| United States | Lifetree Clinical Research | Salt Lake City | Utah |
| United States | University of Rochester | San Antonio | Texas |
| United States | San Diego Hospice & Palliative Care | San Diego | California |
| United States | Pacific Clinical Research | Santa Monica | California |
| United States | Cache Valley Cancer Treatment and Research Clinic, Inc. | West Point | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Cephalon |
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