OsteoarthritisPhase 3NCT00314652
Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
A Phase 3 study testing Buprenorphine transdermal delivery system in people with Osteoarthritis, run by Purdue Pharma LP at 22 sites in United States.
Trial summary
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Buprenorphine transdermal delivery system
- How many people
- 260 participants
- Where
- 22 sitesUnited States
- Study dates
- Jun 1999to Oct 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
- receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
Who cannot join
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
New Century Research Center, Ltd.
Beaverbrook, Ohio, 45431
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
University Clinical Research
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Gainesville Clinical Research Center
Gainesville, Florida, 32605
Physicians Research Associates Jacksonville
Jacksonville, Florida, 32216
Westside Family Medical Center
Kalamazoo, Michigan, 49009
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Mid-South Clinical Research Institute
Memphis, Tennessee, 38120
NJP Clinical Research
Passaic, New Jersey, 07055
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Hawthorne & York, International, Ltd.
Phoenix, Arizona, 85008
Arizona Research Center, LLC
Phoenix, Arizona, 85023
Advanced Clinical Research
Salt Lake City, Utah, 84102
San Diego Arthritis and Osteoporosis Research
San Diego, California, 92120
Scripps Clinic Rancho Bernardo
San Diego, California, 92128
Clinical Research Consultants, Inc.
Trumbull, Connecticut, 06611
ACRC/Arizona Clinical Research
Tucson, Arizona, 85712
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Gold Coast Research, Inc.
Weston, Florida, 33331
PW Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.
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. 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 delivery system
- Keywords
- Osteoarthritis, chronic pain, opioid, 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 delivery systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who were treated successfully for pain management
a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
Secondary outcomes (6)
Average pain intensity and patient satisfaction scores
Incidence of early discontinuation due to lack of efficacy
Time to early discontinuation due to lack of efficacy
Dose level at end of titration
Investigator's assessment of therapeutic response
Diary pain scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startJun 1999
- Study completionOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314652
- Sponsor's protocol ID
- BP99-0203
- Status last verified
- Apr 2006
- First submitted
- 12 Apr 2006
- Last updated
- 3 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee
- ClinicalTrials.gov ID
- NCT00314652
- Acronym / sponsor ID
- BP99-0203
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, chronic pain, opioid, transdermal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Study completion
- Oct 1999
- First posted
- 14 Apr 2006 (estimated)
- Results
- Not posted in the source record
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 assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
- receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
Key exclusion criteria (3 listed)
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
- 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 delivery system | Drug | – |
Primary outcome
Percentage of patients who were treated successfully for pain management
a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
6 secondary outcomes
Average pain intensity and patient satisfaction scores
Incidence of early discontinuation due to lack of efficacy
Time to early discontinuation due to lack of efficacy
Dose level at end of titration
Investigator's assessment of therapeutic response
Diary pain scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2006.
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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.
22 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 delivery system in people with Osteoarthritis, run by Purdue Pharma LP at 22 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: finished, as of the sponsor's last update on 3 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients who were treated successfully for pain management. The study lists 2 primary outcomes in all. 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 May 2006.