OsteoarthritisPhase 3NCT01135524

Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

A Phase 3 study testing Buprenorphine transdermal patch in people with Osteoarthritis, run by Purdue Pharma LP at 89 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 this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Buprenorphine transdermal patch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 89 sitesUnited States
Study dates: Apr 2004to Aug 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 40 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.

Who cannot join

Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study.
Refer to core study for additional inclusion/exclusion information.

Trial locations and contacts

89 sites in 1 country.

City, postcode or hospital

89 sites in 1 country

United States89 sites

Alabama Neurology and Pain Medicine
Alabaster, Alabama, 35007
Research Facility
Altoona, Pennsylvania, 16602
Allergy ARTS
Amarillo, Texas, 79124
Research Facility
Baltimore, Maryland, 21215
Crystal Lake Health Center
Benzonia, Michigan, 49616
Research Facility
Birmingham, Alabama, 35215
The Birmingham Pain Center
Birmingham, Alabama, 35244
University of Alabama Hospital
Birmingham, Alabama, 35249
Research Facility
Boise, Idaho, 83702
Research Facility
Bridgeport, Connecticut, 06606
Research Facility
Brockton, Massachusetts, 02301
Research Facility
Buena Park, California, 90620
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210
Research Facility
Chicago, Illinois, 60610
Research Facility
Chula Vista, California, 91911
Research Facility
Cincinnati, Ohio, 45241
Patuxent Medical Group
Columbia, Maryland, 21045
Research Facility
Columbus, Ohio, 43235
Research Facility
Conroe, Texas, 77304
Research Facility
Coral Gables, Florida, 33134
Family Practice Associates
Corpus Christi, Texas, 78411
New England Center for Clinical Research
Cranston, Rhode Island, 02920
Research Facility
Dallas, Texas, 75218
Research Facility
Dallas, Texas, 75251
Research Facility
Daytona Beach, Florida, 32114
Research Facility
Duncansville, Pennsylvania, 16635
Triangle Orthopaedic Associates
Durham, North Carolina, 27704
Research Facility
Eugene, Oregon, 97404
HealthSouth Metro West Hospital
Fairfield, Alabama, 35064
Research Facility
Fresno, California, 93720
Research Facility
Greensboro, North Carolina, 27401
Radiant Research
Greer, South Carolina, 29651
Research Facility
Hagerstown, Maryland, 21740
Research Facility
Hialeah, Florida, 33013
Research Facility
Hickory, North Carolina, 28601
Cornerstone Research Care
High Point, North Carolina, 27262
Hot Springs Pain Clinic
Hot Springs, Arkansas, 71913
Research Facility
Houston, Texas, 77054
KC Pain Centers East
Independence, Missouri, 64055
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046
Research Facility
Jupiter, Florida, 99458
Rheumatology PC
Kalamazoo, Michigan, 49009
Research Facility
Lansing, Michigan, 48917
Research Facility
Largo, Florida, 33770
Research Facility
Las Vegas, Nevada, 89106
Research Facility
Las Vegas, Nevada, 89117
Research Facility
Los Gatos, California, 95032
Louisville Endocrinology PSC
Louisville, Kentucky, 40213
Research Facility
Madisonville, Kentucky, 42431
Research Facility
Marietta, Georgia, 30060
Research Facility
Mechanicsburg, Pennsylvania, 17055
Idaho Arthritis Osteoporosis
Meridian, Idaho, 83642
Research Facility
Miami, Florida, 33155
Research Facility
Milwaukee, Wisconsin, 53218
Research Facility
New Berlin, Wisconsin, 53151
Research Facility
New Orleans, Louisiana, 70114
Research Facility
New Orleans, Louisiana, 70115
Dolby Providers
New Orleans, Louisiana, 70128
Research Facility
New York, New York, 10021
Research Facility
North Miami Beach, Florida, 33180
Research Facility
Ocala, Florida, 34471
Research Facility
Oklahoma City, Oklahoma, 73103
Research Facility
Ormond Beach, Florida, 32174
Research Facility
Palm Harbor, Florida, 34684
Research Facility
Pembroke Pines, Florida, 33024
Research Facility
Phoenix, Arizona, 85018
Arizona Research Center
Phoenix, Arizona, 85023
Research Facility
Phoenix, Arizona, 85029
Radiant Research
Pinellas Park, Florida, 33781
Research Facility
Plantation, Florida, 33324
Research Facility
Port Orange, Florida, 32127
Research Facility
Pueblo, Colorado, 81008
KRK Medical Research
Richardson, Texas, 75080
Research Facility
Roseville, California, 95661
Research Facility
San Antonio, Texas, 78217
Research Facility
San Antonio, Texas, 78238
NTOUCH Research Corporation
San Diego, California, 92103
Research Facility
San Diego, California, 92120
Research Facility
Spokane, Washington, 99207
Research Facility
Springfield, Illinois, 62704
Research Facility
St Louis, Missouri, 63117
HealthCare Research LLC
St Louis, Missouri, 63141
Research Facility
Syracuse, New York, 13210
Research Facility
Tampa, Florida, 33614
Research Facility
Torrence, California, 90505
Research Facility
Tucson, Arizona, 85712
Research Facility
Upland, California, 91786
Integrated Clinical Trials
West Des Moines, Iowa, 50265
Research Facility
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase

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: Osteoarthritis
Being tested: Buprenorphine transdermal patch
Keywords: Osteoarthritis, Opioid, Transdermal
Medical subject headings: Osteoarthritis

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

Study groups in NCT01135524
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.

The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
Measured: 52 weeks

Timeline

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

Apr 2004Aug 2005

First posted2 Jun 2010 (estimated)
Study startApr 2004
Primary completionAug 2005
Study completionAug 2005

Why it stopped: This study was terminated early for 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 OsteoarthritisStudies 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: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01135524
Sponsor's protocol ID: BUP3019S
Status last verified: Sep 2012
First submitted: 1 Jun 2010
Last updated: 10 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

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All Osteoarthritis 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: A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase
ClinicalTrials.gov ID: NCT01135524
Acronym / sponsor ID: BUP3019S
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Opioid, Transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early for administrative reasons.
Enrolment: 196 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: Aug 2005 (actual)
Study completion: Aug 2005 (actual)
First posted: 2 Jun 2010 (estimated)
Results: Posted 23 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: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 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.

Key exclusion criteria (4 listed)

Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study.
Refer to core study for additional inclusion/exclusion information.

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

Primary outcome

The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 52 weeks
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

Results and safety

Results posted to the registry on 23 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
Extension Phase	196	0

Primary outcome: The Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame: 52 weeks. Number. Unit: participants

Measure	Extension Phase n = 196
Deaths	1
Serious Adverse Events	14
Other Adverse Events in ≥ 4.5% of subjects	93

Population analysed: The Extension Safety Population (N = 196) 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: Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extension Phase	14 of 196 (7.1%)	93 of 196 (47.4%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early for administrative reasons.

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.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.

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

89 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 Osteoarthritis, run by Purdue Pharma LP at 89 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 1 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: stopped early, 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 89 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 23 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?

The Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 52 weeks). 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 NCT01135524.

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.