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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
Not Enrolling
Pain, Cancer

Thank you

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

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

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:


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


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

November 2006

Related Keywords:

  • Pain
  • Cancer
  • Cancer
  • Pain



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