Pain Clinical Trial
Official title:
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
| Verified date | May 2007 |
| 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 long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | November 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cancer Outreach Associates, PC | Abingdon | Virginia |
| United States | Allegheny Pain Management, PC | Altoona | Pennsylvania |
| United States | Southeastern Gynecologic Oncology, LLC | Atlanta | Georgia |
| United States | St. Agnes Healthcare | Baltimore | Maryland |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | Oncology Associates of Oregon | Eugene | Oregon |
| United States | Kentucky Cancer Clinic | Hazard | Kentucky |
| United States | Hot Spring Pain Clinic | Hot Springs | Arkansas |
| United States | Saint Joseph's Mercy Cancer Center | Hot Springs | Arkansas |
| United States | Center for Pain Management | Huntsville | Alabama |
| United States | Florida Institute of Medical Research | Jacksonville | Florida |
| United States | University of Florida Shands Cancer Center at Jacksonville | Jacksonville | Florida |
| United States | Southwest Oncology Associates | Lafayette | Louisiana |
| United States | Hematology Oncology Associates | Lake Worth | Florida |
| United States | St. Mary Medical Center | Langhorne | Pennsylvania |
| United States | University of Wisconsin Medical School | Madison | Wisconsin |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Innovative Medical Research of South Florida | Miami Shores | Florida |
| United States | Hematology and Oncology Specialists | New Orleans | Louisiana |
| United States | Beth Israel Medical Center | New York | New York |
| United States | Mohamed Haq | Pasadena | Texas |
| United States | Arkansas Cancer Institute | Pine Bluff | Arkansas |
| United States | Huron Medical Center | Port Huron | Michigan |
| United States | MedSource Inc | Richmond | Virginia |
| United States | Bond Clinic, Inc | Rolla | Missouri |
| United States | Hunstman Cancer Institute | Salt Lake City | Utah |
| United States | Palliative Care and Pain Medicine | Salt Lake City | Utah |
| United States | Cancer Care Centers of South Texas | San Antonio | Texas |
| United States | North Shore Cancer Research Association | Skokie | Illinois |
| United States | The Cancer Prevention and Treatment Center | Soquel | California |
| United States | Providence Cancer Institute | Southfield | Michigan |
| United States | HealthCare Research, LLC | St. Louis | Missouri |
| United States | Gulf Coast Oncology Association | St. Petersburg | Florida |
| United States | Clinical Pharmacology Services, Inc | Tampa | Florida |
| United States | Northwestern Connecticut Oncology & Hematology Associates | Torrington | Connecticut |
| United States | Arizona Clinical Research Center | Tucson | Arizona |
| United States | Outcomes Research International | Tucson | Arizona |
| United States | PETC Research Group, Inc. | Tulsa | Oklahoma |
| United States | UTHCT (ATTN: Clinical Research) | Tyler | Texas |
| United States | Palm Beach Research | West Palm Beach | Florida |
| United States | Great Basin Clinical Research | West Point | Utah |
| United States | The Center for Clinical Research, LLC | Winston-Salem | North Carolina |
| United States | Florida Medical Clinic, PA | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Cephalon |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tolerability and safety of OraVescent fentanyl when used long-term | |||
| Secondary | Assess the effectiveness of OraVescent fentanyl | |||
| Secondary | Assess the development of incremental tolerance |
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