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Multi-Center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients


Phase 3
18 Years
80 Years
Not Enrolling
Both
Pain, Cancer

Thank you

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 HospitalAllentown, Pennsylvania  18103
Advanced Clinical Research InstituteAnaheim, California  92801
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Pacific Clinical ResearchSanta Monica, California  90404
Gabrail Cancer CenterCanton, Ohio  44718
Clinical Trials & Research Associates, Inc.Montebello, California  90640
Hematology Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
NYU Pain Management CenterNew York, New York  10016
Lifetree Clinical ResearchSalt Lake City, Utah  84106
Great Falls Clinic, LLPGreat Falls, Montana  59405
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Pacific Cancer Medical CenterAnaheim, California  92801
Cullman Oncology and HematologyCullman, Alabama  35058
Compassionate Cancer Care Medical GroupCorona, California  92882
Compassionate Cancer CenterFountain Valley, California  92708
San Diego Hospice & Palliative CareSan Diego, California  92103
Lovelace Scientific ResourcesMiami, Florida  33143
Gulf Coast Pain SpecialistsPensacola, Florida  32503
Center for Prospective OutcomeMarietta, Georgia  30060
Iowa Pain Management Clinic, PCDes Moines, Iowa  50265
Donald BerdeauxGreat Falls, Montana  59405
Southern Nevada Cancer ResearchLas Vegas, Nevada  89106
Research Across AmericaNew York, New York  10021
Brody School of MedicineGreenville, North Carolina  27858
University of RochesterSan Antonio, Texas  78229
Cache Valley Cancer Treatment and Research Clinic, Inc.West Point, Utah  84015