Clinical trial NCT00105287: Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Official title: Multi-center Study Evaluating 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
Breakthrough Pain in cancer patients
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-03-14
Enrollment: 100
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 safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Oncology and Hematology
state: Alabama
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Center
state: California
city: Montebello
country: United States
facility: Clinical Trials & Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Hospice & Palliative Care
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Miami
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Pensacola
country: United States
facility: Gulf Coast Pain Specialists
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of Treasure Coast
state: Florida
city: Marietta
country: United States
facility: Center for Prospective Outcome
state: Georgia
city: Des Moines
country: United States
facility: Iowa Pain Management Clinic, PC
state: Iowa
city: Great Falls
country: United States
facility: Donald Berdeaux
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic, LLP
state: Montana
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research
state: Nevada
city: New York
country: United States
facility: NYU Pain Management Center
state: New York
city: New York
country: United States
facility: Research Across America
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
city: San Antonio
country: United States
facility: University of Rochester
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: West Point
country: United States
facility: Cache Valley Cancer Treatment and Research Clinic, Inc.
state: Utah
Study officials:
References: