Status:
COMPLETED
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Lead Sponsor:
Cephalon
Conditions:
Pain
Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- Opioid or fentanyl intolerance
- Sleep apnea or active brain metastases with increased intracranial pressure
- COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00105287
Start Date
January 1 2005
End Date
September 1 2007
Last Update
May 9 2014
Active Locations (26)
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1
Cullman Oncology and Hematology
Cullman, Alabama, United States, 35058
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
4
Compassionate Cancer Care Medical Group
Corona, California, United States, 92882