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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00343733
First received: June 21, 2006
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: OraVescent Fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: August 2006
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00343733

Locations
United States, Arkansas
Hot Springs Pain Clinic
Hot Springs, Arkansas, United States, 71913
United States, California
Samaritan Center for Medical
Los Gatos, California, United States, 92032
Pacific Neuroscience Medical Group, Inc.
Oxnard, California, United States, 93030
United States, Florida
Centre for Rheumatology
Fort Lauderdale, Florida, United States, 33334
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Atlas Research
Orlando, Florida, United States, 32806
Gold Coast Research, LLC
Plantation, Florida, United States, 33324
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30066
Comprehensive Pain Care, PC
Marietta, Georgia, United States, 30060
United States, Louisiana
Best Clinical Trials, Inc.
New Orleans, Louisiana, United States, 70065
Best Clinical Trials, LLC
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Brigham Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Pain Management Associates
Independence, Missouri, United States, 64055
United States, Montana
Montana Neuroscience Institute
Missoula, Montana, United States, 59802
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Five Towns Neuroscience Research
Lawrence, New York, United States, 11599
United States, North Carolina
PharmQuest
Greensboro, North Carolina, United States, 27401
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Legacy Emanuel Pain Management, PC
Portland, Oregon, United States, 97227
United States, Pennsylvania
Clinical Research Center
West Reading, Pennsylvania, United States, 19611
United States, Virginia
Advanced Pain Management
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00343733     History of Changes
Other Study ID Numbers: C25608/3052/BP/US
Study First Received: June 21, 2006
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
diabetic peripheral neuropathy
postherpetic neuralgia
traumatic injury
complex regional pain syndrome
back pain
neck pain
fibromyalgia
chronic pancreatitis
osteoarthritis

Additional relevant MeSH terms:
Chronic Pain
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 26, 2014