Back Pain Lower Back ChronicPhase 3NCT00313014

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

A Phase 3 study testing Buprenorphine and Oxycodone Immediate-Release in people with Back Pain Lower Back Chronic, run by Purdue Pharma LP at 85 sites in United States.

Terminated

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Back Pain Lower Back Chronic
What is being tested?: Buprenorphine and Oxycodone Immediate-Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 660 participants
Where: 85 sitesUnited States
Study dates: Feb 2004to Sep 2005
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

low back pain for 3 months or longer, confirmed by radiographic evidence.
receiving a stable dose of an opioid analgesic for low back pain.

Who cannot join

taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
Other protocol-specific exclusion/inclusion criteria may apply.

Trial locations and contacts

85 sites in 1 country.

City, postcode or hospital

85 sites in 1 country

United States85 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, Inc.
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, Inc.
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, LLC
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
Oklahoma City, Oklahoma, 73112
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Arthritis & 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
Coastal Medical Research
Port Orange, Florida, 32168
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, 11070
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
Tuscon, Arizona, 85712
Omega Medical Research
Warwick, Rhode Island, 28860
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 Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) 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 situations for the relief of moderate to severe pain.

Conditions: Back Pain Lower Back Chronic
Being tested: Buprenorphine, Oxycodone Immediate-Release
Keywords: Low back pain, opioid, transdermal, Butrans
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.

BuprenorphineDrug
Also called Butrans™
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
BuprenorphineDrug
Also called Butrans™
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone Immediate-ReleaseDrug
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Study groups in NCT00313014
Study group	Role	What they receive
BTDS 5	Active comparator	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. Receives: Drug: Buprenorphine
BTDS 20	Experimental	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. Receives: Drug: Buprenorphine
Oxycodone Immediate-Release	Experimental	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). Receives: Drug: Oxycodone Immediate-Release

What is being measured

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

Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
Measured: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

Secondary outcomes (3)

Mean Daily Number of Supplemental Analgesic Tablets
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Measured: Double-blind phase (84 days)
Oswestry Disability Index (ODI) Score (V 2.0)
The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.
The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)
Measured: Weeks 4, 8, 12
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).
Question 1 is scored on a scale of 1 to 5 and Questions 3 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 the double-blind phase

Timeline

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

Feb 2004Sep 2005

First posted11 Apr 2006 (estimated)
Study startFeb 2004
Primary completionSep 2005
Study completionSep 2005

Why it stopped: Terminated early due to administrative reasons unrelated to efficacy or safety.

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 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 660 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00313014
Sponsor's protocol ID: BUP3015
Status last verified: Aug 2012
First submitted: 10 Apr 2006
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003. Epub 2011 Jul 31.
PubMed 21807566

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

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Enrolling by invitation
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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 Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
ClinicalTrials.gov ID: NCT00313014
Acronym / sponsor ID: BUP3015
Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain, opioid, transdermal, Butrans
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early due to administrative reasons unrelated to efficacy or safety.
Enrolment: 660 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Sep 2005 (actual)
Study completion: Sep 2005 (actual)
First posted: 11 Apr 2006 (estimated)
Results: Posted 29 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BTDS 5	Active comparator	Drug: BuprenorphineBuprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
BTDS 20	Experimental	Drug: BuprenorphineBuprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Oxycodone Immediate-Release	Experimental	Drug: Oxycodone Immediate-ReleaseOxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Who may qualify

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

Key inclusion criteria (2 listed)

low back pain for 3 months or longer, confirmed by radiographic evidence.
receiving a stable dose of an opioid analgesic for low back pain.

Key exclusion criteria (3 listed)

taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
Other protocol-specific exclusion/inclusion 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
BuprenorphineAlso: Butrans™Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.	Drug	BTDS 5
BuprenorphineAlso: Butrans™Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Drug	BTDS 20
Oxycodone Immediate-ReleaseOxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).	Drug	Oxycodone Immediate-Release

Primary outcome

Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Time frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)

3 secondary outcomes

Mean Daily Number of Supplemental Analgesic Tablets
Time frame: Double-blind phase (84 days)
Oswestry Disability Index (ODI) Score (V 2.0)
Time frame: Weeks 4, 8, 12
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
Time frame: Weeks 4, 8, 12 of the double-blind phase

Results and safety

Results posted to the registry on 29 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
Double-blind BTDS 5	221	128
Double-blind BTDS 20	219	146
Double-blind Oxycodone Immediate-Release	220	159

Primary outcome: Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.

Time frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase. Mean (Standard Error). Unit: units on a scale

Measure	Double-blind BTDS 5 n = 221	Double-blind BTDS 20 n = 219	Double-blind Oxycodone Immediate-Release n = 220
Screening	6.36 (0.075)	6.46 (0.084)	6.46 (0.079)
Prerandomization	2.84 (0.075)	2.91 (0.075)	2.74 (0.074)
Week 4	3.79 (0.149)	3.40 (0.128)	3.14 (0.125)
Week 8	3.83 (0.162)	3.35 (0.140)	3.24 (0.145)
Week 12	4.02 (0.179)	3.35 (0.139)	3.26 (0.152)

Double-blind BTDS 5 vs Double-blind BTDS 20: Mean Difference (Final Values): -0.67 (95% CI -0.99 to -0.35), p <.001, Mixed Models Analysis
Double-blind BTDS 5 vs Double-blind Oxycodone Immediate-Release: Mean Difference (Final Values): -0.75 (95% CI -1.07 to -0.44), p <.001, Mixed Models Analysis

Population analysed: Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events occurring 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 or stabilized.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind BTDS 5	6 of 221 (2.7%)	54 of 221 (24.4%)	Not reported
Double-blind BTDS 20	7 of 219 (3.2%)	118 of 219 (53.9%)	Not reported
Double-blind Oxycodone Immediate-Release	9 of 220 (4.1%)	93 of 220 (42.3%)	Not reported
Open-label Run-in Period, BTDS 10/20	10 of 1,160 (0.9%)	389 of 1,160 (33.5%)	Not reported

Limitations and caveats (from the sponsor): BUP3015 was terminated early due to administrative reasons unrelated to efficacy or safety.

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.
Results publication: PubMed 21807566Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003. Epub 2011 Jul 31.

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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.

Martin Hale, MD principal investigator

Gold Coast Research LLC, Weston, FL, USA

85 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 and Oxycodone Immediate-Release in people with Back Pain Lower Back Chronic, run by Purdue Pharma LP at 85 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 3 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 85 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 29 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 Score at Weeks 4, 8, and 12. (time frame: Last 24 hours score at weeks 4, 8, 12 of the 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 NCT00313014, 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 3 Sep 2012.