Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Cephalon

Status and phase: Completed; Phase 3

Conditions: Cancer; Pain

Treatments: Drug: OraVescent fentanyl (OVF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00105287

C25608/3039/BP/US

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)