Postoperative PainPhase 2NCT00315835
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
A Phase 2 study testing Buprenorphine transdermal delivery system in people with Postoperative Pain, run by Purdue Pharma LP at 1 site in United States.
Trial summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Buprenorphine transdermal delivery system
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1996to Nov 1997
- Phase
- Phase 2
- 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
- underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized >/=4 days postoperatively.
- in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for >/=4 days post-surgery.
Who cannot join
- receiving chronic opioid therapy preoperatively for >1 month that was at a total daily dose of >/= 60 mg of oral morphine equivalents.
- have significant concurrent pulmonary conditions.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Place Therapeutic Center
Plantation, Florida, 33324
About this study
Official title: A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) 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. 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
- Postoperative Pain
- Being tested
- Buprenorphine transdermal delivery system
- Keywords
- postoperative pain, opioid, transdermal
- 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 delivery systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical laboratory tests
vital signs
physical examinations
electrocardiograms
elicited opioid side effects
pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
adverse events
application site skin observations
plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination
Secondary outcomes (4)
pain intensity
acceptability of therapy
quality of sleep
rescue dose usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startOct 1996
- Study completionNov 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315835
- Sponsor's protocol ID
- BP96-0104
- Status last verified
- Apr 2006
- First submitted
- 17 Apr 2006
- Last updated
- 19 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT00315835
- Acronym / sponsor ID
- BP96-0104
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, opioid, transdermal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Oct 1996
- Study completion
- Nov 1997
- First posted
- 19 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 of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) 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. 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)
- underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized >/=4 days postoperatively.
- in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for >/=4 days post-surgery.
Key exclusion criteria (3 listed)
- receiving chronic opioid therapy preoperatively for >1 month that was at a total daily dose of >/= 60 mg of oral morphine equivalents.
- have significant concurrent pulmonary conditions.
- 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
clinical laboratory tests
vital signs
physical examinations
electrocardiograms
elicited opioid side effects
pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
adverse events
application site skin observations
plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination
4 secondary outcomes
pain intensity
acceptability of therapy
quality of sleep
rescue dose usage
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 19 Apr 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.
1 site 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 delivery system in people with Postoperative Pain, run by Purdue Pharma LP at 1 site 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 19 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
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?
clinical laboratory tests. The study lists 9 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 19 Apr 2006.