Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain

NCT00463047 | Completed Phase 3 Results

• 1 other identifier: C25608/3055/BP/MN
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 45

Brief Summary

Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.

Conditions

Chronic Pain

Keywords

Breakthrough pain; Opioid-tolerant; Chronic pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Difference (PID15) At 15 Minutes

  Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.

  Immediately pre-dose and fifteen minutes after administration of study drug

Secondary Outcomes (40)

• Pain Intensity Difference (PID 5) at 5 Minutes

  Immediately before and 5 minutes after study drug administration

• Pain Intensity Difference (PID 10) at 10 Minutes

  Immediately before and 10 minutes after administration of study drug

• Pain Intensity Difference (PID 30) at 30 Minutes

  Immediately before and 10 minutes after study drug administration

• Pain Intensity Difference (PID 45) at 45 Minutes

  Immediately before and 45 minutes after study drug administration

• Pain Intensity Difference (PID 60) at 60 Minutes

  Immediately before and 60 minutes after administration of study drug

Study Arms (2)

Fentanyl Buccal Tablets (FBT)

EXPERIMENTAL

This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone

Oxycodone

ACTIVE COMPARATOR

This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone

Interventions

Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone DRUG

Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.

Fentanyl Buccal Tablets (FBT); Oxycodone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has chronic pain of at least 3 months duration associated with: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain,fibromyalgia, chronic pancreatitis, osteoarthritis,or cancer.
• 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 around-the-clock (ATC) therapy for at least 7 days before administration of the first dose of study drug
• 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 and agree to continued use of this method for the duration of the study.
• Any patient with cancer should have a life expectancy of at least 3 months.
• The patient reports an average Pain Intensity (PI) score, over the prior 24 hours, of 6 or less (0=no pain through 10=pain as bad as you can imagine) for their chronic pain.
• The patient experiences, on average, 1 to 4 breakthrough pain (BTP) episodes 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 must be willing and able to successfully self-administer the study drug,comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.

You may not qualify if:

• The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the around-the-clock (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 a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug.
• 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 that will impact the patient's chronic pain and/or BTP.
• 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 FBT.
• The patient has participated in a study involving an investigational drug in the prior 30 days.
• The patient is currently using prescription FBT or immediate-release oxycodone for BTP and is unwilling to undergo re-titration.
• 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 could, 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 an illicit drug or a medication not prescribed for him/her or which is not medically explainable.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (45)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Birmingham Pain Center

Birmingham, Alabama, 35244, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Desert Pain & Rehab Specialists/Redpoint Research

Phoenix, Arizona, 85029, United States

Location

Hope Research Institute

Phoenix, Arizona, 85050, United States

Location

Lovelace Scientific Resources, Inc.

Beverly Hills, California, 90211, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Samaritan Center for Medical Research, Med. Group

Los Gatos, California, 95032, United States

Location

Advanced Diagnostic Pain Treatment Center, PC

New Haven, Connecticut, 06511, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

AvivoClin Clinical Services

Port Orange, Florida, 32127, United States

Location

Lovelace Scientific Resources, Inc.

Sarasota, Florida, 34233, United States

Location

Clinical Research of Tampa Bay, Inc.

Spring Hill, Florida, 34609, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

Center for Prospective Outcome Studies, Inc.

Atlanta, Georgia, 30327, United States

Location

North Georgia Premier Research

Dawnsonville, Georgia, 30534, United States

Location

Taylor Research, LLC

Marietta, Georgia, 30060, United States

Location

DrugStudies America

Marietta, Georgia, 30066, United States

Location

Tristate Arthritis & Rheumatology Center, LLC

Evansville, Indiana, 47714, United States

Location

Rehabilitation Associates of Indiana

Indianapolis, Indiana, 46250, United States

Location

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, 50265, United States

Location

International Clinical Research Institute, Inc.

Overland Park, Kansas, 66211, United States

Location

Kansas City Bone & Joint Clinic, Inc.

Overland Park, Kansas, 66211, United States

Location

Willis-Knighton Pain Management Center

Shreveport, Louisiana, 71103, United States

Location

The Rehabilitation Team West

Baltimore, Maryland, 21228, United States

Location

Mid Atlantic Pain Medicine Center

Pikesville, Maryland, 21208, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States

Location

Metropolitan Hospital Center

New York, New York, 10029, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

PharmQuest

Greensboro, North Carolina, 27401, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Raleigh Neurology Associate

Raleigh, North Carolina, 27607, United States

Location

Columbus Clinical Research

Columbus, Ohio, 43213, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

Greenville Pharmaceutical

Greenville, South Carolina, 29615, United States

Location

Comprehensive Pain Specialists, PLLC

Hendersonville, Tennessee, 37075, United States

Location

Consultants in Pain Research

San Antonio, Texas, 78209, United States

Location

InVisions Consultants, LLC

San Antonio, Texas, 78218, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Chronic Pain; Breakthrough Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Monitor
• Organization: Cephalon, Inc.

1-800-896-5855

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: April 19, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 28, 2012
• Results First Posted: December 14, 2010

Record last verified: 2012-05

Locations

US (45)