A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Neuropathic Pain

Condition	Intervention	Phase
Chronic Neuropathic Pain	Drug: ORAVESCENT Fentanyl Citrate	Phase III

Further Study Details: 

Expected Total Enrollment:  120

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  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, barried 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 the study.
• The patient has chronic neuropathic pain of at least 3 months duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, or complex regional pain syndrome. Patients with other neuropathic 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 of oral morphine/day, or at least 25 mcg transdermal fentanyl/hour, or atleast 30 mg or oxycodone/day, or at least 8 mg hydropmorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-close (ATC) therapy for at least the previous 7 days before enrollment in the study.
• The patient reports an average pain intensity (PI) score, over the prior 24 hours, of less than 7 (0=no pain through 10=worst pain) for their chronic neuropathic pain.
• The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of sever 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 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 their chronic pain.
• The patient has a positive urin screen (UDS) for a medication not prescribed by their physician or no reasonable explanation can be provided to the Cephalon medical monitor.

Please refer to this study by ClinicalTrials.gov identifier  NCT00214955

Arkansas
      Clopton Clinic, Jonesboro,  Arkansas,  72401,  United States
California
      San Diego Arthritis Medical, San Diego,  California,  92106,  United States
      Vertex Clinical Research, Inc., Bakersfield,  California,  93311,  United States
Florida
      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
Georgia
      Center for Prospective Outcome, Marietta,  Georgia,  30060,  United States
      Georgia Medical Research, Marietta,  Georgia,  30060,  United States
Illinois
      American Medical Research, Oak Brook,  Illinois,  60523,  United States
      American Medical Research, Chicago,  Illinois,  60616,  United States
Indiana
      American Medical Research, Valparaiso,  Indiana,  46383,  United States
Iowa
      Iowa Pain Management Clinic, P, Des Moines,  Iowa,  50265,  United States
Kansas
      Mid America Physiatrists, PA, Overland Park,  Kansas,  66211,  United States
Louisiana
      Best Clinical Trial, Inc., New Orleans,  Louisiana,  70115,  United States
North Carolina
      PharmQuest, Greensboro,  North Carolina,  27401,  United States
Washington
      Northwest Clinical Research, Bellevue,  Washington,  98004,  United States

Study ID Numbers:  C25608/3041/BP/US
Last Updated:  September 21, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00214955
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27