Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain

NCT00813488 | Completed Phase 3 Results

• 1 other identifier: C25608/3056/BP/US
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 50

Brief Summary

Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) 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 (PID) at 15 Minutes Post-treatment (PID15)

  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 15 minutes after dosing

Secondary Outcomes (45)

• Pain Intensity Difference (PID) at 5 Minutes Post-treatment

  Immediately pre-dose and 5 minutes after dosing

• Pain Intensity Difference (PID) at 10 Minutes Post-treatment

  Immediately pre-dose and 10 minutes after dosing

• Pain Intensity Difference (PID) at 30 Minutes Post-treatment

  Immediately pre-dose and 30 minutes after dosing

• Pain Intensity Difference (PID) at 45 Minutes Post-treatment

  Immediately pre-dose and 45 minutes after dosing

• Pain Intensity Difference (PID) at 60 Minutes Post-treatment

  Immediately pre-dose and 60 minutes after dosing

Study Arms (2)

Fentanyl buccal tablet first then immediate release oxycodone

EXPERIMENTAL

This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid.

Drug: Fentanyl Buccal Tablet; Drug: Immediate release oxycodone

Immediate Release Oxycodone first then FBT

EXPERIMENTAL

This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid.

Drug: Fentanyl Buccal Tablet; Drug: Immediate release oxycodone

Interventions

Fentanyl Buccal Tablet DRUG

FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain. The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets). For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.

Also known as: CEP-25608

Fentanyl buccal tablet first then immediate release oxycodone; Immediate Release Oxycodone first then FBT

Immediate release oxycodone DRUG

Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain. The maximum single dose would be 60 mg (4 capsules).

Fentanyl buccal tablet first then immediate release oxycodone; Immediate Release Oxycodone first then FBT

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 is currently using at least one 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 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, including a written opioid agreement form, to participate in this study.
• 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 PI score, over the 24 hours prior to screening, 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, at least 1 and less than 5 BTP episodes per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours during the screening period.
• 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 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 a diagnosis of chronic headache or migraine as the primary painful condition with associated BTP.
• 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 the patient's safety or collected data.
• The patient has suicidal ideation at screening or has a history of suicidal ideation within 1 year or history of suicide attempt within 2 years before screening, or a diagnosis of bipolar disorder or history of schizophrenia
• 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 FBT or oral transmucosal fentanyl citrate for BTP.
• The patient is currently using 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (50)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Horizon Research Group, Inc

Mobile, Alabama, 36608, United States

Location

Robert Karns, MD a Medical Corporation

Beverly Hills, California, 90211, United States

Location

Catalina Research Institute, LLC

Chino, California, 91710, United States

Location

Pacific Coast Pain Management

Laguna Hills, California, 92637, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

VA Northern California Health

Mather, California, 95655, United States

Location

New England Research Associates

Trumbull, Connecticut, 06611, United States

Location

Delray Research Associates

Delray Beach, Florida, 33484, United States

Location

Emerald Coast Research Group Inc

Marianna, Florida, 32446, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Gold Coast Research

Plantation, Florida, 33324, United States

Location

Sarasota Pain Medicine Research

Sarasota, Florida, 34238, United States

Location

Suncoast Neuroscience Associates

St. Petersburg, Florida, 33701, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Taylor Research

Marietta, Georgia, 30060, United States

Location

Drug Studies America

Marietta, Georgia, 30066, United States

Location

Georgia Pain Care

Newnan, Georgia, 30265, United States

Location

South Coast Medical Group

Savannah, Georgia, 31406, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Suburban Clinical Research

Bolingbrook, Illinois, 60490, United States

Location

Knight Center for Integrated Health

Peoria, Illinois, 61614, United States

Location

Indiana Medical Research

Elkhart, Indiana, 46514, United States

Location

Rehabilitation Associates of Indiana

Indianapolis, Indiana, 46250, United States

Location

Indiana Pain & Spine Clinic

South Bend, Indiana, 46617, United States

Location

ICRI Inc.

Overland Park, Kansas, 66211, United States

Location

The Pain Treatment Center of the Bluegrass

Lexington, Kentucky, 40503, United States

Location

Gulf Coast Research Associates, Inc

Baton Rouge, Louisiana, 70708, United States

Location

Columbia Medical Practice

Columbia, Maryland, 21045, United States

Location

MidAtlantic Pain Medicine Center

Pikesville, Maryland, 21208, United States

Location

Michigan Neurology Associates PC

Clinton Township, Michigan, 48035, United States

Location

CRC of Jackson

Jackson, Mississippi, 39202, United States

Location

Healthcare Research

Florissant, Missouri, 63031, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Five Towns Neuroscience Research

Cedarhurst, New York, 11516, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Clinical Research Source Inc

Perrysburg, Ohio, 43551, United States

Location

Pain Research of Oregon

Eugene, Oregon, 97401, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

Clinical Research Center

West Reading, Pennsylvania, 19611, United States

Location

Greenville Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Trident Institute of Medical Research, LLC

North Charleston, South Carolina, 29406, United States

Location

South Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

Lovelace Scientific

Austin, Texas, 78759, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Related Publications (1)

• Webster LR, Slevin KA, Narayana A, Earl CQ, Yang R. Fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic cancer and noncancer pain: a randomized, double-blind, crossover study followed by a 12-week open-label phase to evaluate patient outcomes. Pain Med. 2013 Sep;14(9):1332-45. doi: 10.1111/pme.12184. Epub 2013 Jul 15.

  PMID: 23855816 DERIVED

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: Sponsor's Medical Expert, Clinical Research
• Organization: Cephalon, Inc.

1-800-896-5855

Study Officials

• Sponsor's Medical Expert, MD

  Cephalon

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 23, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 28, 2012
• Results First Posted: December 31, 2010

Record last verified: 2012-05

Locations

US (50)