OsteoarthritisPhase 3NCT00313846
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
A Phase 3 study testing Buprenorphine transdermal patch in people with Osteoarthritis, run by Purdue Pharma LP at 44 sites in United States.
Trial summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. 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?
- Yes, some participants may receive a placebo
- How many people
- 529 participants
- Where
- 44 sitesUnited States
- Study dates
- Apr 2003to Jun 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
- clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
- an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
Who cannot join
- ingest opioid analgesics on a daily basis.
- ingest >2500 milligrams (mg) acetaminophen on a daily basis.
- require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Keystone Clinical
Altoona, Pennsylvania, 16602
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462
Advance Pain Medicine
Bakersfield, California, 93311
Stamford Therapeutic Consortium
Bridgeport, Connecticut, 66060
Professional Clinical Research
Cadillac, Michigan, 49601
Low Country Rheumatology
Charleston, South Carolina, 29406
Columbus Internal Medical Associates
Columbus, Indiana, 47201
Eastgate Medical Center
Cypress, California, 90623
Private Practice
Dallas, Texas, 75251
University Clinical Research Deland
DeLand, Florida, 32720
Mountain View Clinical Research
Denver, Colorado, 80209
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Evergreen Clinical Research Associates
Edmonds, Washington, 98026
MediSphere Medical Research Ctr.
Evansville, Indiana, 47714
Team Research of Central Texas
Harker Heights, Texas, 76548
Drug Study Institute
Jupiter, Florida, 33458
University Osteoporosis Ctr
Loma Linda, California, 92354
Non-Surgical Orthopedic & Spine Center
Marietta, Georgia, 30060
Vista Medical Research
Mesa, Arizona, 85206
Primary Care Research
Murray, Kentucky, 42071
Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
New York, New York, 10003
Coastal Medical Research
Orange City, Florida, 32763
Arizona Research Center
Phoenix, Arizona, 85012
Radiant Research
Phoenix, Arizona, 85013
Arizona Research Center
Phoenix, Arizona, 85023
Coastal Medical Research
Port Orange, Florida, 32127
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92108
Scripps Clinic Rancho Bernard
San Diego, California, 92128
CNS Clinical Trials, Inc
San Francisco, California, 94121
ACCU Clinical Research Trials, Inc
Seguin, Texas, 78155
University Orthopedics Center
State College, Pennsylvania, 16801
Internal Medicine Northwest
Tacoma, Washington, 98405
Sound Medical At West Front Primary Care
Traverse City, Michigan, 49684
ACRC/Arizona Clinical Research
Tucson, Arizona, 85715
Advance Pain Management & Rehab
Virgina Beach, Virginia, 23454
Brown Clinic
Watertown, South Dakota, 57201
Palm Beach Research Center
West Palm Beach, Florida, 33409
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611
Integrative Treatment Centers/Rocky Mtn Clin Res
Westminster, Colorado, 80021
Gold Coast Research
Weston, Florida, 33331
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033
All-Trials Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
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
- Keywords
- Chronic pain, opioid, transdermal, osteoarthritis
- 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, 10 or 20 mcg/h applied for 7-day wear.
PlaceboDrug
Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
| Study group | Role | What they receive |
|---|---|---|
| BTDS | Experimental | Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h) Receives: Drug: Buprenorphine transdermal patch |
| Placebo | Placebo comparator | Placebo to match BTDS 5, 10 or 20 mcg/h Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
Inadequate analgesia:
- "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;
- >1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;
- ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
Measured: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods
Secondary outcomes (1)
Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site
The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).
Measured: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from 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 posted12 Apr 2006 (estimated)
- Study startApr 2003
- Primary completionJun 2004
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 529 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
- NCT00313846
- Sponsor's protocol ID
- BUP3012
- Status last verified
- Aug 2012
- First submitted
- 11 Apr 2006
- Last updated
- 3 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
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, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
- ClinicalTrials.gov ID
- NCT00313846
- Acronym / sponsor ID
- BUP3012
- Conditions
- Osteoarthritis
- Keywords
- Chronic pain, opioid, transdermal, osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Posted 28 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 (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
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.
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 patch 5, 10 or 20 micrograms/hour (mcg/h) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match BTDS 5, 10 or 20 mcg/h |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
- an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
Key exclusion criteria (4 listed)
- ingest opioid analgesics on a daily basis.
- ingest >2500 milligrams (mg) acetaminophen on a daily basis.
- require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
- 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, 10 or 20 mcg/h applied for 7-day wear. | Drug | BTDS |
| PlaceboPlacebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. | Drug | Placebo |
Primary outcome
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
Time frame: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods
Inadequate analgesia: * "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or; * >1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or; * ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
1 secondary outcome
Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site
Time frame: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from 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 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.
44 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 44 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: 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 44 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 28 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 Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. (time frame: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods). 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 3 Sep 2012.