OsteoarthritisPhase 3NCT00315458

Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

A Phase 3 study testing Buprenorphine transdermal patch in people with Osteoarthritis, run by Purdue Pharma LP at 48 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

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?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 48 sitesUnited States
Study dates: Dec 2003to Mar 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

clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Who cannot join

requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
Other protocol-specific exclusion/inclusion criteria may apply.

Trial locations and contacts

48 sites in 1 country.

City, postcode or hospital

48 sites in 1 country

United States48 sites

Keystone Clinical Solutions
Altoona, Pennsylvania, 16602
Bay Area Health Clinic
Bay City, Michigan, 48706
Parkway Medical Center
Birmingham, Alabama, 35215
Clinical Research Consultants
Birmingham, Alabama, 35244
Comprehensive Neuroscience Inc
Boynton Beach, Florida, 33437
Holston Medical Group
Bristol, Tennessee, 37620
Southbay Pharma Research
Buena Park, California, 90620
Low Country Rheumatology
Charleston, South Carolina, 29406
Chiefland Medical Center
Chiefland, Florida, 32626
University Clinical Research Deland
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
MediSphere Medical Research Center
Evansville, Indiana, 47714
Florida Medical Research Institute
Gainesville, Florida, 32605
Internal Medicine Northwest
Gurnee, Illinois, 60031
Winston Physician Services, Inc
Haleyville, Alabama, 35565
Team Research of Central Texas
Harker Heights, Texas, 76548
Drug Study Institute
Jupiter, Florida, 33458
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Louisville Medical/Rheumatology
Louisville, Kentucky, 40202
Georgia Medical Research Institute
Marietta, Georgia, 30060
CSS Research
Memphis, Tennessee, 38119
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Private Practice
Muscle Shoals, Alabama, 35661
Beth Israel Medical Center
New York, New York, 10003
Health Research Institute
Oklahoma City, Oklahoma, 73109
Coastal Medical Research
Orange City, Florida, 32763
Ormond Medical Arts Pharmaceutical Res Ctr
Ormond Beach, Florida, 32174
The Arthritis Center
Palm Harbor, Florida, 34684
Avancia Research
Pembroke Pines, Florida, 33024
Radiant Research
Phoenix, Arizona, 85013
Arizona Research Center
Phoenix, Arizona, 85023
Coastal Medical Research
Port Orange, Florida, 32127
Quality Research
San Antonio, Texas, 78209
Prime Care Medical Center
Selmer, Tennessee, 38375
BioMedical Research Associates
Shippensburg, Pennsylvania, 17257
Physicians Clinic of Spokane
Spokane, Washington, 99204
Future Care Studies
Springfield, Massachusetts, 01107
Medex Healthcare Research Inc
St Louis, Missouri, 63108
University Orthopedics Center
State College, Pennsylvania, 16801
Torrence Clinical Research
Torrance, California, 90505
Clinic for Rheumatic Diseases
Tuscaloosa, Alabama, 35406
ACRC/Arizona Clinical Research
Tuscon, Arizona, 85715
Advanced Pain Management and Rehab Hilltop Med Center
Virginia Beach, Virginia, 23454
Sentara Medical Group
Virginia Beach, Virginia, 23462
Omega Medical Research
Warwick, Rhode Island, 02886
Brown Clinic
Watertown, South Dakota, 57201
Palm Beach Research Center
West Palm Beach, Florida, 33409
Gold Coast Research LLC
Weston, Florida, 33321

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

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, Placebo 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 applied for 7-day wear.
Placebo transdermal patchDrug
Placebo to match buprenorphine transdermal patch 10 or 20.

Study groups in NCT00315458
Study group	Role	What they receive
BTDS	Experimental	Buprenorphine transdermal patches 10 or 20 mcg/h Receives: Drug: Buprenorphine transdermal patch
Placebo	Placebo comparator	Placebo to match buprenorphine transdermal patch 10 or 20 Receives: Drug: Placebo 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
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
Measured: 483 days

Timeline

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

Dec 2003Mar 2005

First posted18 Apr 2006 (estimated)
Study startDec 2003
Primary completionMar 2005
Study completionMar 2005

Why it stopped: 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00315458
Sponsor's protocol ID: BUP3011 and BUP3011S
Status last verified: Aug 2012
First submitted: 17 Apr 2006
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov

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 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
ClinicalTrials.gov ID: NCT00315458
Acronym / sponsor ID: BUP3011 and BUP3011S
Conditions: Osteoarthritis
Keywords: osteoarthritis, opioid, transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Administrative reasons.
Enrolment: 107 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Dec 2003
Primary completion: Mar 2005 (actual)
Study completion: Mar 2005 (actual)
First posted: 18 Apr 2006 (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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BTDS	Experimental	Drug: Buprenorphine transdermal patchBuprenorphine transdermal patches 10 or 20 mcg/h
Placebo	Placebo comparator	Drug: Placebo transdermal patchPlacebo to match buprenorphine transdermal patch 10 or 20

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Key exclusion criteria (3 listed)

requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
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
Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch applied for 7-day wear.	Drug	BTDS
Placebo transdermal patchPlacebo to match buprenorphine transdermal patch 10 or 20.	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time frame: 483 days
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.

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
Double-blind Placebo Patch	51	48
Double-blind BTDS 10/20	56	44
Run-in Period BTDS 5/10/20	159	107
Extension Phase BTDS 5/10/20	39	10

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

Time frame: 483 days. Number. Unit: participants

Measure	Double-blind Placebo n = 51	Double-blind BTDS n = 56	Run-in Period n = 159	Overall BTDS Exposure n = 159
Death	0	1	0	1
Serious adverse events	1	2	1	5
All Other Adverse Events in ≥ 4.5% of Subjects	14	22	60	82

Population analysed: The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.

Adverse events

Time frame: Subjects with AEs that were ongoing at subject's last study visit were followed until resolution or 30 days after last visit, whichever came first. AEs reported during 7 days following last visit were followed until resoultion or 30 days after last visit.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind Placebo Patch	1 of 51 (2%)	14 of 51 (27.5%)	Not reported
Double-blind BTDS 10/20	2 of 56 (3.6%)	22 of 56 (39.3%)	Not reported
Run-in Period	1 of 159 (0.6%)	60 of 159 (37.7%)	Not reported
Overall BTDS Exposure	5 of 159 (3.1%)	82 of 159 (51.6%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early for administrative reasons. The efficacy data are not presented since the primary objective of this study was changed identifying it as a safety study.

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.

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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.

48 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 48 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 48 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 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?

Number of Participants With Adverse Events (AEs) as a Measure of Safety (time frame: 483 days). 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 NCT00315458.

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.