Clinical trial NCT00105937: OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Official title: Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Cancer
Keywords: Cancer
Pain
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Tolerability and safety of OraVescent fentanyl when used long-term
Secondary outcomes:
measure: Assess the effectiveness of OraVescent fentanyl
measure: Assess the development of incremental tolerance
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Center for Pain Management
state: Alabama
city: Tucson
country: United States
facility: Outcomes Research International
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Hot Springs
country: United States
facility: Hot Spring Pain Clinic
state: Arkansas
city: Hot Springs
country: United States
facility: Saint Joseph's Mercy Cancer Center
state: Arkansas
city: Pine Bluff
country: United States
facility: Arkansas Cancer Institute
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Soquel
country: United States
facility: The Cancer Prevention and Treatment Center
state: California
city: Torrington
country: United States
facility: Northwestern Connecticut Oncology & Hematology Associates
state: Connecticut
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Shands Cancer Center at Jacksonville
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Miami Shores
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: St. Petersburg
country: United States
facility: Gulf Coast Oncology Association
state: Florida
city: Tampa
country: United States
facility: Clinical Pharmacology Services, Inc
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Southeastern Gynecologic Oncology, LLC
state: Georgia
city: Skokie
country: United States
facility: North Shore Cancer Research Association
state: Illinois
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Lafayette
country: United States
facility: Southwest Oncology Associates
state: Louisiana
city: New Orleans
country: United States
facility: Hematology and Oncology Specialists
state: Louisiana
city: Baltimore
country: United States
facility: St. Agnes Healthcare
state: Maryland
city: Port Huron
country: United States
facility: Huron Medical Center
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Institute
state: Michigan
city: Rolla
country: United States
facility: Bond Clinic, Inc
state: Missouri
city: St. Louis
country: United States
facility: HealthCare Research, LLC
state: Missouri
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Tulsa
country: United States
facility: PETC Research Group, Inc.
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management, PC
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Pasadena
country: United States
facility: Mohamed Haq
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Tyler
country: United States
facility: UTHCT (ATTN: Clinical Research)
state: Texas
city: Salt Lake City
country: United States
facility: Hunstman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Palliative Care and Pain Medicine
state: Utah
city: West Point
country: United States
facility: Great Basin Clinical Research
state: Utah
city: Abingdon
country: United States
facility: Cancer Outreach Associates, PC
state: Virginia
city: Richmond
country: United States
facility: MedSource Inc
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
References: