OsteoarthritisPhase 3NCT00312221
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
A Phase 3 study testing Buprenorphine and oxycodone immediate-release in people with Osteoarthritis, run by Purdue Pharma LP at 23 sites in United States.
Trial summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. 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 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
- 418 participants
- Where
- 23 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
- Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
Who cannot join
- Not currently taking and tolerating opioids.
- 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 osteoarthritis.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
Professional Clinical Research Crystal Lake Health Center
Benzonia, Michigan, 49616
Parkway Medical Center
Birmingham, Alabama, 35215
Miray Medical Center
Brockton, Massachusetts, 23010
International Clinical Research Network
Chula Vista, California, 91910
Pharm Quest
Greensboro, North Carolina, 27401
Med Search Professional Group/Pharmaceutical C-Trials Inc.
Hurst, Texas, 76054
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Drug Study Institute
Jupiter, Florida, 33458
Rheumatology PC
Kalamazoo, Michigan, 49009
Innovative Research of West Florida, Inc.
Largo, Florida, 33770
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
Georgia Medical Research Institute
Marietta, Georgia, 30060
Non- Surgical Orthopedic & Spine Center, P.C.
Marietta, Georgia, 30060
International Medical Research
Ormond Beach, Florida, 32174
Peninsula Research, Inc.
Ormond Beach, Florida, 32174
Southern Colorado Clinic
Pueblo, Colorado, 81008
Clinical Trials Research
Roseville, California, 95661
Texas Medical Research Associates
San Antonio, Texas, 78238
Accelovance
San Diego, California, 92108
The Arthritis Center
Springfield, Illinois, 62704
Torrance Clinical Research
Torrance, California, 90505
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release 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, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
Read the detailed description
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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, oxycodone immediate-release
- 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.
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 immediate-release 40 mg (two 5-mg capsules every 6 hours).
| 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 (Oxy IR) 40 mg | 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" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
Measured: Weeks 4, 8, and 12 of the double-blind phase
Secondary outcomes (3)
The Mean Daily Number of Supplemental Analgesic Medication Tablets
The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.
Measured: Double-blind phase (84 days)
The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.
The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst).
Measured: Weeks 4, 8 and 12 of the double-blind phase
The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 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, and 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.
- First posted7 Apr 2006 (estimated)
- Study startApr 2004
- Primary completionJul 2005
- Study completionAug 2005
Why it stopped: terminated early for administrative reasons unrelated to safety or efficacy
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312221
- Sponsor's protocol ID
- BUP3019
- Status last verified
- Sep 2012
- First submitted
- 6 Apr 2006
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain
- ClinicalTrials.gov ID
- NCT00312221
- Acronym / sponsor ID
- BUP3019
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, opioid, transdermal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated early for administrative reasons unrelated to safety or efficacy
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Posted 15 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 objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release 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, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
Detailed description
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, 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 (Oxy IR) 40 mg | Experimental | Drug: oxycodone immediate-releaseOxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). |
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, confirmed by radiographic evidence within the last 2 years.
- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
Key exclusion criteria (4 listed)
- Not currently taking and tolerating opioids.
- 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 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 |
|---|---|---|
| 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 immediate-release 40 mg (two 5-mg capsules every 6 hours). | Drug | Oxycodone Immediate-Release (Oxy IR) 40 mg |
Primary outcome
"Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
Time frame: Weeks 4, 8, and 12 of the double-blind phase
The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
3 secondary outcomes
The Mean Daily Number of Supplemental Analgesic Medication Tablets
Time frame: Double-blind phase (84 days)
The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
Time frame: Weeks 4, 8 and 12 of the double-blind phase
The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Time frame: Weeks 4, 8, and 12 of the Double-blind Phase
Results and safety
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
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.
23 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 Osteoarthritis, run by Purdue Pharma LP at 23 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 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 23 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 15 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" Scores at Weeks 4, 8, and 12 of the Double-blind Phase. (time frame: Weeks 4, 8, and 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?
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.