Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon ) Identifier:
First received: September 14, 2005
Last updated: May 8, 2014
Last verified: May 2014

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Estimated Enrollment: 120
Study Start Date: September 2005
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 hydromorphone/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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00214955

United States, Arkansas
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Vertex Clinical Research, Inc.
Bakersfield, California, United States, 93311
San Diego Arthritis Medical
San Diego, California, United States, 92106
United States, Florida
Clinical Research of W Florida
Clearwater, Florida, United States, 33765
Florida Institute of Medical R
Jacksonville, Florida, United States, 32207
Clinical Pharmacology Services
Tampa, Florida, United States, 33617
Gold Coast Research
Weston, Florida, United States, 33331
United States, Georgia
Center for Prospective Outcome
Marietta, Georgia, United States, 30060
Georgia Medical Research
Marietta, Georgia, United States, 30060
United States, Illinois
American Medical Research
Chicago, Illinois, United States, 60616
American Medical Research
Oak Brook, Illinois, United States, 60523
United States, Indiana
American Medical Research
Valparaiso, Indiana, United States, 46383
United States, Iowa
Iowa Pain Management Clinic, P
Des Moines, Iowa, United States, 50265
United States, Kansas
Mid America Physiatrists, PA
Overland Park, Kansas, United States, 66211
United States, Louisiana
Best Clinical Trial, Inc.
New Orleans, Louisiana, United States, 70115
United States, North Carolina
Greensboro, North Carolina, United States, 27401
United States, Washington
Northwest Clinical Research
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon ) Identifier: NCT00214955     History of Changes
Other Study ID Numbers: C25608/3041/BP/US
Study First Received: September 14, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breakthrough Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 01, 2015