OsteoarthritisPhase 3NCT01141283

Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

A Phase 3 study testing Buprenorphine transdermal patch in people with Osteoarthritis, run by Purdue Pharma LP at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 40 to 75 years
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: 290 participants
Where: 42 sitesUnited States
Study dates: Apr 2003to Jul 2004
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Who cannot join

Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
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

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

Research Facility
Atlantis, Florida, 33462
Advanced Pain Medicine
Bakersfield, California, 93311
Research Facility
Bellevue, Washington, 98026
Research Facility
Bridgeport, Connecticut, 06606
Great Lakes Family Care
Cadillac, Michigan, 49601
Low Country Rheumatology, PA
Charleston, South Carolina, 29406
Research Facility
Columbus, Indiana, 47201
Research Facility
Cresson, Pennsylvania, 16630
Orange County Clinical Research
Cypress, California, 90630
Research Facility
Dallas, Texas, 75251
Allergy, Asthma, Arthritis & Lung
Daytona Beach, Florida, 32114
University Clinical Research Deland
DeLand, Florida, 32720
Research Facility
Denver, Colorado, 80209
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Research Facility
Evansville, Indiana, 47712
Research Facility
Harker Heights, Texas, 76548
Research Facility
Jupiter, Florida, 33458
Research Facility
Marietta, Georgia, 30060
Vista Medical Research Inc.
Mesa, Arizona, 85206
Primary Care Medical Center
Murray, Kentucky, 42071
Beth Israel/Dept. of Pain
New York, New York, 10021
Coastal Medical Research
Orange City, Florida, 32763
Arthrocare, Arthritis Care and Research
Phoenix, Arizona, 85012
Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
Phoenix, Arizona, 85015
Arizona Research Center
Phoenix, Arizona, 85023
Research Facility
Plantation, Florida, 33324
Research Facility
San Antonio, Texas, 78217
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120
Research Facility
San Diego, California, 92128
Research Facility
San Francisco, California, 94121
Research Facility
Seguin, Texas, 78155
University Orthopedics & Sport Medicine Center
State College, Pennsylvania, 16801
Internal Medicine Northwest
Tacoma, Washington, 98405
Research Facility
Traverse City, Michigan, 49684
Research Facility
Tucson, Arizona, 85712
Hilltop Medical Center
Virginia Beach, Virginia, 23454
Central Plains Clin-Brown Site
Watertown, South Dakota, 57201
Research Facility
West Palm Beach, Florida, 33409
Research Facility
West Reading, Pennsylvania, 19611
Granger Medical Clinic
West Valley City, Utah, 84120
Research Facility
Westminster, Colorado, 80031
Research Facility
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

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
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patchDrug
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
Buprenorphine transdermal patchDrug
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Study groups in NCT01141283
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: 6 months.

Timeline

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

Apr 2003Jul 2004

First posted10 Jun 2010 (estimated)
Study startApr 2003
Primary completionJul 2004
Study completionJul 2004

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01141283
Sponsor's protocol ID: BUP3012S
Status last verified: Aug 2012
First submitted: 2 Jun 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
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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 of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase
ClinicalTrials.gov ID: NCT01141283
Acronym / sponsor ID: BUP3012S
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Opioid, Transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Apr 2003
Primary completion: Jul 2004 (actual)
Study completion: Jul 2004 (actual)
First posted: 10 Jun 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.

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
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 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Key exclusion criteria (3 listed)

Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
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 patchBuprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Drug	BTDS
Buprenorphine transdermal patchBuprenorphine transdermal patch 10 mcg/h applied for 7-day wear	Drug	BTDS
Buprenorphine transdermal patchBuprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Drug	BTDS

Primary outcome

The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months.
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 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
Extension Phase (BTDS 5, 10, or 20)	290	202

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

Time frame: 6 months.. Number. Unit: participants

Measure	Extension Phase (BTDS 5, 10, or 20) n = 290
Deaths	0 (0)
Serious Adverse Events	6
Adverse Events 4.5%	202

Population analysed: The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during extension phase.

Adverse events

Time frame: Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extension Phase (BTDS 5, 10, or 20)	6 of 290 (2.1%)	202 of 290 (69.7%)	Not reported

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 Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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
Osteoarthritis of the Knee

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.

42 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 42 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 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: finished, 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 42 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?

The Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 6 months.). 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 NCT01141283.

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.