OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon
• Treatments: Citric Acid; Fentanyl

Criteria

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 malignancy

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