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

Phase 3

Completed

• Conditions: Pain; Cancer

• Registration Number: NCT00105937
• Lead Sponsor: Cephalon

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-03-18
• Study First Submitted QC: 2005-03-18
• Study First Posted: 2005-03-21
• Study Completion: 2006-11
• Status Verified: 2007-05
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Outcome Measures

Name	Time	Method
Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance

Trial Locations

Locations (43)

Center for Pain Management; 🇺🇸 Huntsville, Alabama, United States

Outcomes Research International; 🇺🇸 Tucson, Arizona, United States

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

Hot Spring Pain Clinic; 🇺🇸 Hot Springs, Arkansas, United States

Saint Joseph's Mercy Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

Arkansas Cancer Institute; 🇺🇸 Pine Bluff, Arkansas, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

The Cancer Prevention and Treatment Center; 🇺🇸 Soquel, California, United States

Northwestern Connecticut Oncology & Hematology Associates; 🇺🇸 Torrington, Connecticut, United States

Florida Institute of Medical Research; 🇺🇸 Jacksonville, Florida, United States

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