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

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00105937

First received: March 18, 2005

Last updated: June 27, 2012

Last verified: May 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	March 18, 2005
Last Updated Date	June 27, 2012
Start Date ^ICMJE	April 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Tolerability and safety of OraVescent fentanyl when used long-term
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00105937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Assess the effectiveness of OraVescent fentanyl Assess the development of incremental tolerance
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Official Title ^ICMJE	Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pain Cancer
Intervention ^ICMJE	Drug: OraVescent fentanyl citrate
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	November 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00105937
Other Study ID Numbers ^ICMJE	099-15
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Teva Pharmaceutical Industries
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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