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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



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