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

This study has been completed.

First Received: March 18, 2005 Last Updated: May 25, 2007 History of Changes

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00105937

Purpose

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.

Condition	Intervention	Phase
Pain Cancer	Drug: OraVescent fentanyl citrate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multi-Center, Open Label, Long-Term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Citric acid Fentanyl Fentanyl Citrate Sodium Citrate

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Outcome Measures:

Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance

Estimated Enrollment:	300
Study Start Date:	April 2004
Estimated Study Completion Date:	November 2006

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105937

Show 43 Study Locations

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Study ID Numbers:	099-15
Study First Received:	March 18, 2005
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00105937 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

Cancer
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on March 18, 2010