Status:
COMPLETED
OraVescent Fentanyl (OVF) for the 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 long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
Detailed Description
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 patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00105937
Start Date
April 1 2004
End Date
November 1 2006
Last Update
June 29 2012
Active Locations (43)
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1
Center for Pain Management
Huntsville, Alabama, United States, 35801
2
Outcomes Research International
Tucson, Arizona, United States, 85711
3
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
4
Hot Spring Pain Clinic
Hot Springs, Arkansas, United States, 71913