Overview

Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cephalon
Treatments:
Fentanyl
Criteria
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