Low Back PainPhase 3NCT00490919

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

A Phase 3 study testing Buprenorphine transdermal system in people with Low Back Pain, run by Purdue Pharma LP at 86 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Buprenorphine transdermal system
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 539 participants
Where: 86 sitesUnited States
Study dates: Jun 2007to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

86 sites in 1 country.

City, postcode or hospital

86 sites in 1 country

United States86 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Low Back Pain
Being tested: Buprenorphine transdermal system, Placebo
Keywords: Chronic pain, opioid, transdermal, Moderate to severe chronic low back pain
Medical subject headings: Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Buprenorphine transdermal systemDrug
Also called Butrans™
Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
PlaceboDrug
transdermal system (placebo) worn for 7 days

Study groups in NCT00490919
Study group	Role	What they receive
Double-blind BTDS 10 or 20	Experimental	Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear Receives: Drug: Buprenorphine transdermal system
Double-blind Placebo TDS	Placebo comparator	Placebo transdermal system to match BTDS patches, applied for 7 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 outcomes (2)

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.
Measured: 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.
Measured: Weeks 4, 8, 12 of double-blind phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Oct 2008

First posted25 Jun 2007 (estimated)
Study startJun 2007
Primary completionJul 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 539 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00490919
Sponsor's protocol ID: BUP3024
Status last verified: Sep 2012
First submitted: 21 Jun 2007
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 21945130

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00490919
Acronym / sponsor ID: BUP3024
Conditions: Low Back Pain
Keywords: Chronic pain, opioid, transdermal, Moderate to severe chronic low back pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 539 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jul 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 25 Jun 2007 (estimated)
Results: Posted 9 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Double-blind BTDS 10 or 20	Experimental	Drug: Buprenorphine transdermal systemBuprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear
Double-blind Placebo TDS	Placebo comparator	Drug: PlaceboPlacebo transdermal system to match BTDS patches, applied for 7 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Buprenorphine transdermal systemAlso: Butrans™Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days	Drug	Double-blind BTDS 10 or 20
Placebotransdermal system (placebo) worn for 7 days	Drug	Double-blind Placebo TDS

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 9 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label Run-in Period	1,024	541
Double-blind BTDS 10 or 20	0	0
Double-blind Placebo TDS	0	0

Primary outcome: 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.. Mean (Standard Deviation). Unit: Units on a scale

Measure	Double-blind BTDS n = 256	Double-blind Placebo TDS n = 283
Screening	7.24 (1.263)	7.17 (1.223)
Prerandomization	2.57 (1.283)	2.56 (1.207)
Week 12 - Primary outcome	3.83 (2.738)	4.38 (2.690)

Double-blind BTDS vs Double-blind Placebo TDS: Mean Difference (Final Values): -0.58 (95% CI -1.02 to -0.14), p = .0104, Mixed Models Analysis

Population analysed: The full analysis population (FAP) (N = 541) \[539\] consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. (Two subjects did not have safety data.)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind BTDS 10, 20	3 of 256 (1.2%)	52 of 256 (20.3%)	Not reported
Double-blind Placebo TDS 10, 20	2 of 283 (0.7%)	63 of 283 (22.3%)	Not reported
Open-label Run-in Period, BTDS 5, 10, 20	4 of 1,024 (0.4%)	437 of 1,024 (42.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21945130Steiner 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.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

86 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Buprenorphine transdermal system in people with Low Back Pain, run by Purdue Pharma LP at 86 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490919, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.