A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of
ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain in Opioid-Tolerant Patients
with Chronic Low Back Pain
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
- The patient is willing to provide written informed consent to participate in this
study.
- The patient is 18 through 80 years of age.
- Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing
potential, using a medically accepted method of birth control (ie, barrier method with
spermicide, steroidal contraceptive [oral, transdermal, implanted, or injected
contraceptives must be used in conjunction with a barrier method], or intrauterine
device [IUD]) and agree to continued use of this method for the duration of this
study.
- The patient has a diagnosis of chronic low back pain, resulting in functional
disability of at least 3 months duration and is associated with any of the following:
osteoarthritis, degenerative disc disease, or spondylolisthesis. Patients with other
low back pain etiologies may qualify for the study with permission from the Cephalon
medical monitor or designee.
- The patient is currently using 1 of the following: at least 60 mg/day or oral
morphine/day, or at least 25 mcg transdermal fentanyl/hour, or at least 30 mcg
oxycodone/day, as a stable dose of around-the-clock (ATC) therapy for at least the
previous 7 days before enrollment into the study.
- The patient reports an average pain intensity score, over the prior 24 hours, of less
than 7 (0=no pain through 10=worst pain) for their chronic low back pain.
- The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares
of severe or excruciating pain) per day while taking ATC opioid therapy, and on
average, the duration of each BTP episode is less than 4 hours.
- The patient currently uses opioid therapy for alleviation of BTP episodes, occuring at
the location of the chronic pain, and achieves at least partial relief.
- The patient is able to effectively self-administer the study drug.
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following
criteria are met:
- The patient has uncontrolled or rapidly escalating pain as determined by the
investigator (ie, the ATC therapy may be expected to change between the first and last
treatments with study drug), or has pain uncontrolled by therapy that could adversely
impact the safety of the patient or that could be compromised by treatment with study
drug.
- The patient has known or suspected hypersensitivities, allergies, or other
contraindications to any ingredient in the study drug.
- The patient has a recent history (within 5 years) or current evidence of alcohol or
other substance abuse.
- The patient has cardiopulmonary disease that would, in the opinion of the
investigator, significantly increase the risk of treatment with potent synthetic
opioids.
- The patient has medical psychiatric disease that, in the opinion of the investigator,
would compromise collected data.
- The patient is expected to have surgery during the study and it is anticipated that
the surgery will alleviate the patient's pain.
- The patient has had therapy before study drug treatment that, in the opinion of the
investigator, could alter pain or response to pain medication.
- The patient is pregnant or lactating.
- The patient has participated in a previous study with ORAVESCENT fentanyl.
- The patient has participated in a study involving an investigational drug in the
previous 30 days.
- The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before
the first treatment with study drug.
- The patient has any other medical condition or is receiving concomitant
medication/therapy (eg, regional nerve block) that would, in the opinion of the
investigator, compromise the patient's safety or compliance with the study protocol,
or compromise collected data.
- The patient is involved in active litigation in regard to their chronic pain.
- The patient has a positive urine drug screen (UDS) for a medication not prescribed by
their physician or no reasonable explanation can be provided to the Cephalon medical
monitor.
Clopton Clinic, Jonesboro, Arkansas 72401, United States
San Diego Arthritis Medical, San Diego, California 92106, United States
Vertex Clinical Research, Inc., Bakersfield, California 93311, United States
Clinical Pharmacology Services, Tampa, Florida 33617, United States
Florida Institute of Medical R, Jacksonville, Florida 32207, United States
Gold Coast Research, Weston, Florida 33331, United States
Clinical Research of W Florida, Clearwater, Florida 33765, United States
Center for Prospective Outcome, Marietta, Georgia 30060, United States
Georgia Medical Research, Marietta, Georgia 30060, United States
American Medical Research, Oak Brook, Illinois 60523, United States
American Medical Research, Chicago, Illinois 60616, United States
American Medical Research, Valparaiso, Indiana 46383, United States
Iowa Pain Management Clinic, P, Des Moines, Iowa 50265, United States
Mid America Physiatrists, PA, Overland Park, Kansas 66211, United States
Best Clinical Trial, Inc., New Orleans, Louisiana 70115, United States
PharmQuest, Greensboro, North Carolina 27401, United States
Northwest Clinical Research, Bellevue, Washington 98004, United States
