Clinical trial NCT00228605: Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
Official title: An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Migraine
Diabetic Neuropathies
Osteoarthritis
Keywords: Pain
Sudden Pain
Flares
noncancer
low back pain
neuropathic pain
osteoarthritis pain
migraine
chronic headache
diabetic peripheral neuropathy
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 500
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 for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.


Eligibility criteria: Inclusion Criteria:

* Chronic pain diagnosis
* Opioid tolerant
* Has on average 1-4 breakthrough pain episodes per day

Exclusion Criteria:

* Drug abuse history
* Cardiopulmonary disease
* Monoamine oxidase inhibitors (MAOIs)
* Expected to have surgery to relieve the pain

Primary outcomes:
measure: Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
Secondary outcomes:
measure: Assess the patients' quality of life through questionnaires
measure: Assess the patients' overall medication preferences
measure: Assess the patients' overall medication performance
Other outcomes:
Locations:
city: Calera
country: United States
facility: MedSearch
state: Alabama
city: Hoover
country: United States
facility: Clinical Research Consultants, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Daytona Beach
country: United States
facility: Radiant Research-Daytona Beach
state: Florida
city: St. Petersburg
country: United States
facility: Advent Clinical Research Centers, Inc.
state: Florida
city: Weston
country: United States
facility: Gold Coast Research
state: Florida
city: Atlanta
country: United States
facility: Center for Prospective Outcome Studies, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Advent Clinical Research Centers, Inc.
state: Georgia
city: Marietta
country: United States
facility: Center for Prospective Outcome Studies, Inc.
state: Georgia
city: Roswell
country: United States
facility: North Fulton Regional Hospital Pain Center
state: Georgia
city: Smyrna
country: United States
facility: Carmen Research
state: Georgia
city: Boise
country: United States
facility: Orthopedic Health Care
state: Idaho
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Evansville
country: United States
facility: Tri-State Arthritis & Rheumatology Center, LLC
state: Indiana
city: Des Moines
country: United States
facility: Iowa Pain Management Clinic, PC
state: Iowa
city: Overland Park
country: United States
facility: Mid-America Physiatrists, PA
state: Kansas
city: Rockville
country: United States
facility: Capital Clinical Research Associates, LLC
state: Maryland
city: Boston
country: United States
facility: Brigham Women's Hospital, Attn: Pain Trials Center
state: Massachusetts
city: Wellesley Hills
country: United States
facility: MedVadis Research
state: Massachusetts
city: St. Louis
country: United States
facility: Medex Healthcare Research Center
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research - St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Beth Page
country: United States
facility: Northshore University Hospital
state: New York
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: Oklahoma City
country: United States
facility: The Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Southern Oregon Health & Wellness
state: Oregon
city: West Reading
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Morristown
country: United States
facility: Healthstar Physicians
state: Tennessee
city: Sugar Land
country: United States
facility: Biopharma Research Associates
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: South Burlington
country: United States
facility: Pain Management Center
state: Vermont
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Rowan Research
state: Washington
Study officials:
affiliation: Cephalon
name: Gwendolyn Neibler, DO
role: STUDY_DIRECTOR
References: