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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343733
• Other study ID #: C25608/3052/BP/US
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2006
• Last updated: May 8, 2014
• Start date: August 2006
• Est. completion date: July 2007

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Chronic Pain
• Pain

Intervention

Drug:
• OraVescent Fentanyl

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Brigham Women's Hospital	Boston	Massachusetts
United States	Centre for Rheumatology	Fort Lauderdale	Florida
United States	PharmQuest	Greensboro	North Carolina
United States	Hot Springs Pain Clinic	Hot Springs	Arkansas
United States	Pain Management Associates	Independence	Missouri
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Five Towns Neuroscience Research	Lawrence	New York
United States	Samaritan Center for Medical	Los Gatos	California
United States	Comprehensive Pain Care, PC	Marietta	Georgia
United States	Drug Studies America	Marietta	Georgia
United States	Montana Neuroscience Institute	Missoula	Montana
United States	Best Clinical Trials, Inc.	New Orleans	Louisiana
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	Atlas Research	Orlando	Florida
United States	Pacific Neuroscience Medical Group, Inc.	Oxnard	California
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Legacy Emanuel Pain Management, PC	Portland	Oregon
United States	Advanced Pain Management	Virginia Beach	Virginia
United States	Clinical Research Center	West Reading	Pennsylvania
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.