OsteoarthritisPhase 3NCT00320801

Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

A Phase 3 study testing Buprenorphine transdermal patch in people with Osteoarthritis, run by Purdue Pharma LP at 66 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?: No, everyone receives an active treatment
How many people: 188 participants
Where: 66 sitesUnited States
Study dates: Jan 2004to 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

osteoarthritis of the hip, knee, or spine for 1 year or longer.
taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

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 conditions in addition to osteoarthritis.
Other protocol-specific exclusion/inclusion criteria may apply.

Trial locations and contacts

66 sites in 1 country.

City, postcode or hospital

66 sites in 1 country

United States66 sites

Keystone Clinical Solutions, Inc.
Altoona, Pennsylvania, 16602
Crest Clinical Research, Inc
Anaheim, California, 92804
NuLife Clinical Research, Inc.
Anaheim, California, 92805
Arthritis Clinic of No. Virginia
Arlington, Virginia, 22205
Private Practice
Arvada, Colorado, 80005
Crescent Medical Assoc.
Astoria, New York, 11102
Pinnacle Trials, Inc.
Atlanta, Georgia, 30329
Clinical Investigative Services Med College of Georgia
Augusta, Georgia, 30912
Private Practice
Aventura, Florida, 33180
Midwest Regional Research
Bellbrook, Ohio, 45305
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Parkway Medical Center
Birmingham, Alabama, 35215
Edwards Lake Medical Center
Birmingham, Alabama, 35235
Odyssey Research Services
Bismarck, North Dakota, 58501
Professional Clinical Research
Cadillac, Michigan, 49601
Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
Charlotte, North Carolina, 28207
Cherry Hill Orthopedic Surgeons
Cherry Hill, New Jersey, 08002
Alpha Clinical Research
Clarksville, Tennessee, 37043
Medical Research Associates
Clearwater, Florida, 33761
Orange County Clinical Research
Cypress, California, 90630
Mountainview Clinical Research
Denver, Colorado, 80209
Albermarle Family Practice
Elizabeth City, North Carolina, 27909
Research Center of the Ozarks, , MO
Everton, Missouri, 65646
America's Doctor (SMO)
Gurnee, Illinois, 60031
Central Arkansas Research
Hot Springs, Arkansas, 71913
Rheumatogogy Associates of N. Alabama,
Huntsville, Alabama, 35801
Holston Medical Group
Kingsport, Tennessee, 37660
Vantage Clinical Research Group
Lacey, Washington, 98516
Private Practice
Laguna Hills, California, 90404
Andwell Research
Laguna Niguel, California, 92677
Valerius Medical Group & Research Center Inc.
Long Beach, California, 90802
Anesthesiology and Pain Management
Los Gatos, California, 95032
Private Practice
Medford, New Jersey, 08055
Rouge Valley Clinical Research
Medford, Oregon, 97504
Southern Oregon Health & Wellness
Medford, Oregon, 97504
LifeSpan Clinical Research
Miami, Florida, 33186
Integrity Clinical Research, LLC (SMO)
Milan, Tennessee, 38358
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106
Dolby Providers, Inc.
New Orleans, Louisiana, 70128
Private Practice
Oak Park, Michigan, 48237
Ocala Rheumatology Research Center
Ocala, Florida, 34474
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
The Arthritis & Osteoporosis Center
Orangeburg, South Carolina, 29118
Sidney Hillman Medical Center
Philadelphia, Pennsylvania, 19103
Arcuri Clinical Research
Philadelphia, Pennsylvania, 19142
Private Practice
Plainview, New York, 11803
MedSource
Richmond, Virginia, 23229
Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, 34769
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, 34769
Lake Michigan Clinical Research and Consulting, Inc.
Saint Joseph, Michigan, 49085
LifeTree Clinical Reseach
Salt Lake City, Utah, 84106
J. Lewis Research Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research Foothill Family Clinic South
Salt Lake City, Utah, 84121
Scripps Clinic Ranchro Bernardo
San Diego, California, 92128
Orrin M. Troum & Medical Associates
Santa Monica, California, 90404
Sarasota Arthritis Center
Sarasota, Florida, 34239
University Neurology
Sarasota, Florida, 34243
Meadowbrook Research
Scottsdale, Arizona, 85251
Research Solutions, LLC
Searcy, Arizona, 72143
Arthritis Northwest
Seattle, Washington, 98166
State University of NY at Stonybrook
Stony Brook, New York, 11794
Univeristy of Medicine and Dentistry of New Jersey
Stratford, New Jersey, 08084
Lyle, Austin Alexander PA
Tulsa, Oklahoma, 74104
Diablo Clinical Research
Walnut Creek, California, 94598
New Hanover Medical Research
Wilmington, North Carolina, 28412
Clinical Trials Northwest
Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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: Chronic pain, osteoarthritis, transdermal
Medical subject headings: Osteoarthritis, Chronic 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 20 mcg/h applied for 7-day wear

Study groups in NCT00320801
Study group	Role	What they receive
BTDS 5	Active comparator	Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear Receives: Drug: Buprenorphine transdermal patch
BTDS 20	Experimental	Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear 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 (AEs) as a Measure of Safety.
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Measured: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)

Timeline

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

Jan 2004Mar 2005

First posted3 May 2006 (estimated)
Study startJan 2004
Primary completionMar 2005
Study completionMar 2005

Why it stopped: This study was 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 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: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00320801
Sponsor's protocol ID: BUP3014 and BUP3014S
Status last verified: Aug 2012
First submitted: 28 Apr 2006
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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: A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.
ClinicalTrials.gov ID: NCT00320801
Acronym / sponsor ID: BUP3014 and BUP3014S
Conditions: Osteoarthritis
Keywords: Chronic pain, osteoarthritis, transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to administrative reasons.
Enrolment: 188 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Mar 2005 (actual)
Study completion: Mar 2005 (actual)
First posted: 3 May 2006 (estimated)
Results: Posted 20 Sep 2010

Clinical summary

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

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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 5	Active comparator	Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
BTDS 20	Experimental	Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch 20 mcg/h, applied for 7-day wear

Who may qualify

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

Key inclusion criteria (2 listed)

osteoarthritis of the hip, knee, or spine for 1 year or longer.
taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

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 conditions in addition to osteoarthritis.
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 5 mcg/h applied for 7-day wear	Drug	BTDS 5
Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Drug	BTDS 20

Primary outcome

The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Time frame: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).

Results and safety

Results posted to the registry on 20 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
Run-in Period	188	96
Double-blind BTDS 5	0	0
Double-blind BTDS 20	0	0
Extension Phase	0	0

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

Time frame: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase). Number. Unit: Participants

Measure	Double-blind BTDS 5 n = 47	Double-blind BTDS 20 n = 49	Run-in Period n = 188	Overall BTDS Exposure n = 188
Deaths	0	0	0	0
Serious adverse events	1	1	2	6
Other Adverse Events in ≥ 4.5% of subjects	17	22	52	101

Population analysed: The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study.

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 5	1 of 47 (2.1%)	17 of 47 (36.2%)	Not reported
Double-blind BTDS 20	1 of 49 (2%)	22 of 49 (44.9%)	Not reported
Open-label Run-in Period	2 of 188 (1.1%)	52 of 188 (27.7%)	Not reported
Overall BTDS Exposure	6 of 188 (3.2%)	101 of 188 (53.7%)	Not reported

Limitations and caveats (from the sponsor): Study terminated due to administrative reasons. The primary objective was changed to a safety study prior to unblinding.

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.

Sarah O'Keefe, BSN study chair

Purdue Pharma L.P., Stamford, CT

66 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 66 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 66 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 20 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 (AEs) as a Measure of Safety. (time frame: Throughout BTDS exposure (Includes run-in period, double-blind phase and 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 NCT00320801.

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.