Clinical trial NCT00343733: Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Official title: A 12-Week Open-Label Study With 3 Within-Patient Double-Blind Placebo-Controlled Periods to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: diabetic peripheral neuropathy
postherpetic neuralgia
traumatic injury
complex regional pain syndrome
back pain
neck pain
fibromyalgia
chronic pancreatitis
osteoarthritis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.


Eligibility criteria: 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 \[oral, transdermal, implanted, and injected contraceptives must be used in conjunction with a barrier method\], or intrauterine device \[IUD\]) and agree to continued use of this method for the duration of the study.
* The patient has chronic pain of at least 3 months' duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (documented diagnosis), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with, and written approval from, the Cephalon Medical Monitor.
* The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of ATC therapy for at least the previous 30 days prior to enrollment in the study.
* The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for his/her chronic 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, occurring at the location of the chronic pain, and achieves at least partial relief.
* The patient is able to effectively self-administer the study drug and complete the electronic diary.

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 or 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 the chronic pain currently being treated.
* The patient has a positive urine drug screen (UDS) for a medication not prescribed by the physician currently treating the chronic pain.

Primary outcomes:
measure: The primary objective is to evaluate the efficacy of OraVescent fentanyl treatment compared with placebo treatment following 12 weeks of treatment in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Hot Springs Pain Clinic
state: Arkansas
city: Los Gatos
country: United States
facility: Samaritan Center for Medical
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Atlas Research
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Marietta
country: United States
facility: Comprehensive Pain Care, PC
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: New Orleans
country: United States
facility: Best Clinical Trials, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: Boston
country: United States
facility: Brigham Women's Hospital
state: Massachusetts
city: Independence
country: United States
facility: Pain Management Associates
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute
state: Montana
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Lawrence
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Portland
country: United States
facility: Legacy Emanuel Pain Management, PC
state: Oregon
city: West Reading
country: United States
facility: Clinical Research Center
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Advanced Pain Management
state: Virginia
Study officials:
References: