Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain

Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Buprenorphine transdermal system; Drug: Placebo

Detailed Description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

• Study Type: Interventional
• Enrollment (Actual): 539
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Research Facility
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Radiant Research; Phoenix Southeast
    • Phoenix, Arizona, United States, 85029
      • Research Facility
    • Phoenix, Arizona, United States, 85032
      • Research Facility
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center Inc.
  • California
    • Anaheim, California, United States, 92801
      • Research Facility
    • Beverly Hills, California, United States, 90211
      • Lovelace Scientific Resources, Inc.
    • Carmichael, California, United States, 95608
      • Research Facility
    • City of Industry, California, United States, 91748
      • Advance Care Medical Group
    • Downey, California, United States, 90241
      • Research Facility
    • Foothill Ranch, California, United States, 92610
      • Research Facility
    • Sacramento, California, United States, 95831
      • Research Facility
    • San Luis Obispo, California, United States, 93405
      • Research Facility
  • Colorado
    • Littleton, Colorado, United States, 80128
      • Research Facility
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Research Facility
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Clearwater, Florida, United States, 33765
      • Research Facility
    • Deland, Florida, United States, 32720
      • University Clinical Research
    • Delray Beach, Florida, United States, 33484
      • Arthritis Associates of S. FL
    • Ft. Myers, Florida, United States, 33907
      • Research Facility
    • Holly Hill, Florida, United States, 32117-2257
      • Century Clinical Research, Inc.
    • Jupiter, Florida, United States, 33458-7200
      • Research Facility
    • Largo, Florida, United States, 33770
      • Research Facility
    • Merritt Island, Florida, United States, 32953
      • Research Facility
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic
    • Orlando, Florida, United States, 32806
      • Research Facility
    • Plantation, Florida, United States, 33324
      • Research Facility
    • Port Orange, Florida, United States, 32127
      • Research Facility
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Flor
    • Tampa, Florida, United States, 33613
      • Research Facility
    • West Palm Beach, Florida, United States, 33409
      • Research Facility
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Independent Neurodiagnostic Clinic
    • Dawsonville, Georgia, United States, 30534
      • Research Facility
    • Decatur, Georgia, United States, 30033
      • Druid Oaks Health Center
    • Marietta, Georgia, United States, 30066
      • Research Facility
    • Marietta, Georgia, United States, 30060
      • Research Facility
  • Hawaii
    • Honolulu, Hawaii, United States, 96814-4526
      • Research Facility
  • Idaho
    • Boise, Idaho, United States, 83702
      • Research Facility
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Rehabilitation Association of IN
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Research Facility
    • Prairie Village, Kansas, United States, 66206
      • CTT Consultants, Inc.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Dolby Research, LLC
    • New Orleans, Louisiana, United States, 70114
      • Research Facility
    • New Orleans, Louisiana, United States, 70115
      • Research Facility
    • Shreveport, Louisiana, United States, 71103
      • Research Facility
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Research Facility
    • Haverhill, Massachusetts, United States, 01830-6141
      • East Coast Clinical Research
    • Springfield, Massachusetts, United States, 01103
      • Research Facility
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Research Facility
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Research Facility
  • Missouri
    • Florissant, Missouri, United States, 63031
      • Research Facility
    • St. Louis, Missouri, United States, 63117
      • Research Facility
    • St. Louis, Missouri, United States, 63141
      • Research Facility
    • St. Louis, Missouri, United States, 63141
      • Sports Med Consultants, PC
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Research Facility
    • Las Vegas, Nevada, United States, 89123
      • Research Facility
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources
  • New York
    • New York, New York, United States, 10004
      • Research Facility
    • New York, New York, United States, 10022
      • Research Facility
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Research Facility
    • Greensboro, North Carolina, United States, 27401
      • Research Facility
    • Morgantown, North Carolina, United States, 28655
      • Research Facility
  • Ohio
    • Cincinatti, Ohio, United States, 45245
      • Community Research
    • Cincinnati, Ohio, United States, 45242
      • Research Facility
    • Columbus, Ohio, United States, 43213
      • Research Facility
    • Columbus, Ohio, United States, 43235
      • Research Facility
    • Toledo, Ohio, United States, 43623
      • Research Facility
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Research Facility
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Research Facility
    • Medford, Oregon, United States, 97504-8311
      • Research Facility
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Research Facility
    • Chicora, Pennsylvania, United States, 16025
      • Research Facility
    • Duncansville, Pennsylvania, United States, 16635
      • Research Facility
    • Mechanicsburg, Pennsylvania, United States, 17055
      • Research Facility
    • West Reading, Pennsylvania, United States, 19611
      • Research Facility
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • New England Center for Clinical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Anderson Family Care, PA
  • Texas
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • Killeen, Texas, United States, 76543
      • Research Facility
    • Plano, Texas, United States, 75093
      • Research Facility
    • San Antonio, Texas, United States, 78205-1116
      • Research Facility
    • San Antonio, Texas, United States, 78229
      • Research Facility
    • Sugarland, Texas, United States, 77479
      • Research Facility
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Research Facility
  • Virginia
    • Roanoke, Virginia, United States, 24018
      • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
• Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
• Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

Exclusion Criteria:

• Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
• Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
• Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double-blind BTDS 10 or 20; Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear	Drug: Buprenorphine transdermal system; Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days; Other Names: Butrans™
Placebo Comparator: Double-blind Placebo TDS; Placebo transdermal system to match BTDS patches, applied for 7 days	Drug: Placebo; transdermal system (placebo) worn for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.	Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.	Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase	Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.	weeks 2-12
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase	The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.	Weeks 4, 8, 12 of double-blind phase

Collaborators and Investigators

• Sponsor: Purdue Pharma LP

Publications and helpful links

General Publications

• Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011 Dec;42(6):903-17. doi: 10.1016/j.jpainsymman.2011.04.006. Epub 2011 Sep 25.

Helpful Links

• Product Information

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: June 21, 2007
• First Submitted That Met QC Criteria: June 22, 2007
• First Posted (Estimate): June 25, 2007

Study Record Updates

• Last Update Posted (Estimate): September 10, 2012
• Last Update Submitted That Met QC Criteria: September 5, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: transdermal; opioid; Chronic pain; Moderate to severe chronic low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: BUP3024