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

Condition(s) targeted: Pain

Intervention: OraVescent Fentanyl (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Primary outcome: 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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Hot Springs Pain Clinic, Hot Springs, Arkansas 71913, United States

Samaritan Center for Medical, Los Gatos, California 92032, United States

Pacific Neuroscience Medical Group, Inc., Oxnard, California 93030, United States

Centre for Rheumatology, Fort Lauderdale, Florida 33334, United States

Atlas Research, Orlando, Florida 32806, United States

Gold Coast Research, LLC, Plantation, Florida 33324, United States

Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States

Drug Studies America, Marietta, Georgia 30066, United States

Comprehensive Pain Care, PC, Marietta, Georgia 30060, United States

Best Clinical Trials, Inc., New Orleans, Louisiana 70065, United States

Best Clinical Trials, LLC, New Orleans, Louisiana 70115, United States

Brigham Women's Hospital, Boston, Massachusetts 02115, United States

Pain Management Associates, Independence, Missouri 64055, United States

Montana Neuroscience Institute, Missoula, Montana 59802, United States

Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States

Five Towns Neuroscience Research, Lawrence, New York 11599, United States

Center for Clinical Research, Winston-Salem, North Carolina 27103, United States

PharmQuest, Greensboro, North Carolina 27401, United States

Legacy Emanuel Pain Management, PC, Portland, Oregon 97227, United States

Clinical Research Center, West Reading, Pennsylvania 19611, United States

Advanced Pain Management, Virginia Beach, Virginia 23454, United States

Starting date: August 2006
Ending date: July 2007
Last updated: November 9, 2007