Postoperative PainPhase 2NCT00403234
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
A Phase 2 study testing Buprenorphine transdermal patch in people with Postoperative Pain, run by Purdue Pharma LP at 5 sites in United States.
Trial summary
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Buprenorphine transdermal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2006to Aug 2007
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
- Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.
Who cannot join
- Subjects who have pain or disability in a site other than the operative joint.
- Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
- Subjects whose body mass index (BMI) is 40 or more.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, 21218
Southeastern Clinical Research Consultants
Orlando, Florida, 32804
Arizona Research Center
Phoenix, Arizona, 85023
Accurate Clinical Trials, Inc
San Clemente, California, 92672
Sewickley Valley Hospital
Sewickley, Pennsylvania, 15143
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.
Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
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
- Postoperative Pain
- Being tested
- Buprenorphine transdermal patch, Placebo BTDS
- Keywords
- Postoperative pain, opioid, transdermal, TKA (total knee arthroplasty)
- Medical subject headings
- Pain, Postoperative
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 10 mcg/h applied for 7-day wear.
Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
Placebo BTDSDrug
Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
| Study group | Role | What they receive |
|---|---|---|
| BTDS 10 | Experimental | Buprenorphine transdermal patch 10 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 |
| BTDS 30 | Experimental | Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear Receives: Drug: Buprenorphine transdermal patch |
| Placebo TDS | Placebo comparator | Placebo patches were similar to BTDS 10 and 20. Receives: Drug: Placebo BTDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
Measured: From signed informed consent to 7 days after end of study (approx. 35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionAug 2007
Why it stopped: due to administrative reasons not related to efficacy or safety.
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 Postoperative PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT00403234
- Sponsor's protocol ID
- BUP2003
- Status last verified
- Aug 2012
- First submitted
- 21 Nov 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00403234
- Acronym / sponsor ID
- BUP2003
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, opioid, transdermal, TKA (total knee arthroplasty)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to administrative reasons not related to efficacy or safety.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Nov 2006 (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 objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.
Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
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
- 4
| Arm | Type | Receives |
|---|---|---|
| BTDS 10 | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch 10 mcg/h applied for 7-day wear |
| BTDS 20 | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| BTDS 30 | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch 30 mcg/h applied for 7-day wear |
| Placebo TDS | Placebo comparator | Drug: Placebo BTDSPlacebo patches were similar to BTDS 10 and 20. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
- Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.
Key exclusion criteria (3 listed)
- Subjects who have pain or disability in a site other than the operative joint.
- Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
- Subjects whose body mass index (BMI) is 40 or more.
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 10 mcg/h applied for 7-day wear. | Drug | BTDS 10 |
| Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. | Drug | BTDS 20 |
| Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear. | Drug | BTDS 30 |
| Placebo BTDSPlacebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear. | Drug | Placebo TDS |
Primary outcome
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time frame: From signed informed consent to 7 days after end of study (approx. 35 days)
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buprenorphine transdermal patch in people with Postoperative Pain, run by Purdue Pharma LP at 5 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of Participants With Adverse Events (AEs) as a Measure of Safety (time frame: From signed informed consent to 7 days after end of study (approx. 35 days)). 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.