Back Pain Lower Back ChronicPhase 3NCT01125917

Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

A Phase 3 study testing Buprenorphine transdermal patch in people with Back Pain Lower Back Chronic, run by Purdue Pharma LP at 84 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Back Pain Lower Back Chronic
What is being tested?: Buprenorphine transdermal patch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 354 participants
Where: 84 sitesUnited States
Study dates: Jun 2004to Jan 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 who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase

Who cannot join

Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Trial locations and contacts

84 sites in 1 country.

City, postcode or hospital

84 sites in 1 country

United States84 sites

Keystone Clinical Research
Altoona, Pennsylvania, 16602
NuLife Clinical Research, Inc.
Anaheim, California, 92805
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Valley Pain Specialists
Bethlehem, Pennsylvania, 18016
Lovelace Scientific Resources
Beverly Hills, California, 90211
Birmingham Pain Center
Birmingham, Alabama, 35244
Arthritis Clinical Intervention Program
Birmingham, Alabama, 35249
Odyssey Research
Bismarck, North Dakota, 58502
Pain Care Boise
Boise, Idaho, 83702
Holston Medical Group
Bristol, Tennessee, 37620
Tri Cities Medical Research
Bristol, Tennessee, 37620
Northern California Research Corp
Carmichael, California, 95608
Pain and Orthopedic Neurology , Charlotte Spine Center,
Charlotte, North Carolina, 28207
Metrolina Medical Research
Charlotte, North Carolina, 28209
Pain and Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610
Chiefland Medical Center
Chiefland, Florida, 32626
International Clinical Research Network
Chula Vista, California, 91911
New England Center Clinical Research
Cranston, Rhode Island, 29200
Galenos Research
Dallas, Texas, 75251
University Clinical Research Deland
DeLand, Florida, 32720
Medical Associates Clinics
Dubuque, Iowa, 52002
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Triangle Orthopaedic Associates
Durham, North Carolina, 27704
GFI Research Center
Evansville, Indiana, 47714
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Benchmark Research
Fort Worth, Texas, 76135
Shreenath Clinical Service
Fountain Valley, California, 92708
Pharmquest
Greensboro, North Carolina, 27401
Winston Physician Services, Inc
Haleyville, Alabama, 35565
Team Research of Central Texas
Harker Heights, Texas, 76548
Lovelace Scientific Resources
Henderson, Nevada, 89014
Hot Springs Pain Clinic
Hot Springs, Arkansas, 71913
Drug Study Institute
Jupiter, Florida, 33458
Rheumatology PC
Kalamazoo, Michigan, 49009
Holston Medical Group
Kingsport, Tennessee, 37660
Innovative Research of West Florida, Inc.
Largo, Florida, 33770
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
Georgia Medical Research Institute
Marietta, Georgia, 30060
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055
Idaho Arthritis and Osteoporosis Center
Meridian, Idaho, 83742
New Orleans Clinical Trial Management Inc.
Metairie, Louisiana, 70006
MedArk Clinical Research
Morgantown, North Carolina, 28655
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
Research Center of Louisiana
New Orleans, Louisiana, 70115
Research Across America
New York, New York, 10022
Pivotal Research Centers
North Las Vegas, Nevada, 89030
Renstar Medical
Ocala, Florida, 34471
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
Associated Medical Services Inc
Oklahoma City, Oklahoma, 73112
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, 29118
Dean Medical Center
Oregon, Wisconsin, 53575
Peninsula Research Inc.
Ormond Beach, Florida, 32174
Vince and Associates Clinical Research
Overland Park, Kansas, 66211
The Arthritis Center
Palm Harbor, Florida, 34684
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Arizona Research Center Inc
Phoenix, Arizona, 85023
Radiant Research
Phoenix, Arizona, 85029
Gold Coast Research, LLC
Plantation, Florida, 33324
CTT, Inc.
Prairie Village, Kansas, 66206
Southern Colorado Clinic
Pueblo, Colorado, 81008
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
KRK Medical Research
Richardson, Texas, 75080
U of Calif at Davis, Med Ctr, Pain Management Center
Sacramento, California, 95817
Lake Michigan Clinical Research & Consulting, Inc.
Saint Joseph, Michigan, 49085
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Benchmark Research
San Angelo, Texas, 76904
Unlimited Research
San Antonio, Texas, 78233
Texas Medical Research Associates
San Antonio, Texas, 78238
Accelovance
San Diego, California, 92108
BioMedical Research Associates
Shippensburg, Pennsylvania, 17257
Clinical Trial Network Oaks Medical Center
Spring, Texas, 77386
Future Care Studies
Springfield, Massachusetts, 01103
Medex Healthcare Research Inc
St Louis, Missouri, 63108
HealthCare Research
St Louis, Missouri, 63141
University Orthopedics Center
State College, Pennsylvania, 16801
Atlanta Knee & Shoulder Clinic
Stockbridge, Georgia, 30281
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Omega Medical Research
Warwick, Rhode Island, 02886
Brown Clinic
Watertown, South Dakota, 57201
Palm Beach Research Center
West Palm Beach, Florida, 33409
N. Texas Neuro Research
Wichita Falls, Texas, 76301
Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015

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 situations for the relief of moderate to severe pain.

Conditions: Back Pain Lower Back Chronic
Being tested: Buprenorphine transdermal patch
Keywords: Low back pain, Opioid, Transdermal
Medical subject headings: Low Back Pain

What participants receive

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

Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.

Study groups in NCT01125917
Study group	Role	What they receive
BTDS	Experimental	Buprenorphine transdermal patch Receives: Drug: Buprenorphine transdermal patch

What is being measured

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

Number of Participants With Adverse Events (AEs) as a Measure of Safety
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Measured: 52-week extension phase

Timeline

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

Jun 2004Jan 2008

First posted19 May 2010 (estimated)
Study startJun 2004
Primary completionSep 2005
Study completionJan 2008

Why it stopped: Terminated early due to administrative reasons.

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.
Other trials for Back Pain Lower Back ChronicStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 354 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125917
Sponsor's protocol ID: BUP3015S
Status last verified: Aug 2012
First submitted: 17 May 2010
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
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
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Back Pain Lower Back Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
ClinicalTrials.gov ID: NCT01125917
Acronym / sponsor ID: BUP3015S
Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain, Opioid, Transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early due to administrative reasons.
Enrolment: 354 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Sep 2005 (actual)
Study completion: Jan 2008 (actual)
First posted: 19 May 2010 (estimated)
Results: Posted 21 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BTDS	Experimental	Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch

Who may qualify

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

Key inclusion criteria (2 listed)

Subjects who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase

Key exclusion criteria (1 listed)

Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

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 patchAlso: Butrans™Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.	Drug	BTDS
Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.	Drug	BTDS
Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.	Drug	BTDS

Primary outcome

Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time frame: 52-week extension phase
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).

Results and safety

Results posted to the registry on 21 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
Total BTDS 5, 10, 20	354	15

Primary outcome: Number of Participants With Adverse Events (AEs) as a Measure of Safety

Time frame: 52-week extension phase. Number. Unit: participants

Measure	Total BTDS 5, 10, 20 n = 354
Death	1
Serious adverse events	20
All other adverse events in ≥ 4.5% of subjects	153

Population analysed: The Extension Safety Population (N = 354) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.

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 or sequelae resolved.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total BTDS 5, 10, 20	20 of 354 (5.6%)	153 of 354 (43.2%)	Not reported

Limitations and caveats (from the sponsor): BUP3015S was terminated early due to administrative reasons unrelated to efficacy or safety. There was full evaluation of safety but no evaluation of efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Back Pain Lower Back Chronic

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
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

Deborah L Steiner, MD, MS study director

Purdue Pharma LP

84 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 patch in people with Back Pain Lower Back Chronic, run by Purdue Pharma LP at 84 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 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 84 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. 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 21 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?

Number of Participants With Adverse Events (AEs) as a Measure of Safety (time frame: 52-week extension 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 NCT01125917.

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 3 Sep 2012.