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

September 5, 2012 updated by: Purdue Pharma LP

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
539

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: weeks 2-12
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
Time Frame: Weeks 4, 8, 12 of 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue Pharma LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BUP3024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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