Chronic PainPhase 3NCT00313833
Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
A Phase 3 study testing Buprenorphine transdermal delivery system in people with Chronic Pain, run by Purdue Pharma LP at 18 sites in United States.
Trial summary
This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Buprenorphine transdermal delivery system
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- Dec 2000to Nov 2001
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- residing in a nursing home, assisted living environment, or any type of supervised living situation in which the principal investigator maintained primary responsibility for the analgesic management of the resident.
- chronic pain of musculoskeletal origin who had been managed with short-acting opioids.
Who cannot join
- taking >90 mg oral morphine sulfate per day (during any single day) or >50 mcg/hr of transdermal fentanyl or its equivalent.
- activity restricted totally to bed rest.
- have cancer-related pain.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Center for Pain Management
Altoona, Pennsylvania, 16601
Advanced Clinical Research Institute
Anaheim, California, 92801
Atlantic Medical Group LLC
Baltimore, Maryland, 21208
Geriatric Associates of America Inc PA
Baytown, Texas, 77520
Birmingham Health Center
Birmingham, Alabama, 35235
Regency Manor
Columbus, Ohio, 43207
Life Care Home Health Services
Delray Beach, Florida, 33445
Glengariff Health Care Center
Glen Cove, New York, 11542
Wisconsin Veterans Home
King, Wisconsin, 54946
Ward Parkway Health Services
Leawood, Kansas, 66206
Associated Medical Services Inc
Oklahoma City, Oklahoma, 73112
Arizona Research Center
Phoenix, Arizona, 85023
Town Center Village
Portland, Oregon, 97266
Associated Physicians of Southbury
Southbury, Connecticut, 06488
Bio-Test Clinic
Springfield, Missouri, 65807
Kings Harbor Multicare Center
The Bronx, New York, 10469
Bortz Health Care of Warren
Warren, Michigan, 48089
LAS/Health and Wellness Center
Zelienople, Pennsylvania, 16063
About this study
Official title: A Randomized, Double Blind, Pilot Evaluation of the Effectiveness of BTDS Versus Placebo on Health Outcomes Associated With Analgesic Management of Elderly Residents in Supervised Living Environments
This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. The treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) 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
- Chronic Pain
- Being tested
- Buprenorphine transdermal delivery system
- Keywords
- Chronic pain, elderly, supervised living, opioid, transdermal
- Medical subject headings
- 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.
Pilot study.
Secondary outcomes (25)
The following outcome variables were assessed:
average pain intensity in the last 24 hours
acceptability of analgesic therapy
number of nighttime awakenings due to pain last night
quality of sleep
bowel status during the last 24 hours
pain management evaluation
symptom evaluation
staff evaluation of functional independence
resident-defined activity impairment scale
treatment satisfaction questionnaire
Health Assessment Questionnaire
Timed "Up & Go" evaluation
trail making test
digit span test
end of study global evaluation of therapeutic response
modified mini-mental state
examination and geriatric depression scale.
The following measures of health resource utilization were assessed:
use of analgesic medications (usual care plus BTDS) by product type
use of analgesic medications (usual care plus BTDS) by medication and dosage form
use of pain-related adjuvant medications by product type
number of phone calls to physicians for pain management
number of physician visits for pain management
and use of medications for the treatment of drug-related adverse events.
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 startDec 2000
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 3
- 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
- NCT00313833
- Sponsor's protocol ID
- BUP3002
- Status last verified
- Apr 2006
- First submitted
- 10 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 Randomized, Double Blind, Pilot Evaluation of the Effectiveness of BTDS Versus Placebo on Health Outcomes Associated With Analgesic Management of Elderly Residents in Supervised Living Environments
- ClinicalTrials.gov ID
- NCT00313833
- Acronym / sponsor ID
- BUP3002
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, elderly, supervised living, opioid, transdermal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Study completion
- Nov 2001
- First posted
- 12 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.
This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. The treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) 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
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- residing in a nursing home, assisted living environment, or any type of supervised living situation in which the principal investigator maintained primary responsibility for the analgesic management of the resident.
- chronic pain of musculoskeletal origin who had been managed with short-acting opioids.
Key exclusion criteria (4 listed)
- taking >90 mg oral morphine sulfate per day (during any single day) or >50 mcg/hr of transdermal fentanyl or its equivalent.
- activity restricted totally to bed rest.
- have cancer-related 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 delivery system | Drug | – |
Primary outcome
Pilot study.
25 secondary outcomes
The following outcome variables were assessed:
average pain intensity in the last 24 hours
acceptability of analgesic therapy
number of nighttime awakenings due to pain last night
quality of sleep
bowel status during the last 24 hours
pain management evaluation
symptom evaluation
staff evaluation of functional independence
resident-defined activity impairment scale
treatment satisfaction questionnaire
Health Assessment Questionnaire
Timed "Up & Go" evaluation
trail making test
digit span test
end of study global evaluation of therapeutic response
modified mini-mental state
examination and geriatric depression scale.
The following measures of health resource utilization were assessed:
use of analgesic medications (usual care plus BTDS) by product type
use of analgesic medications (usual care plus BTDS) by medication and dosage form
use of pain-related adjuvant medications by product type
number of phone calls to physicians for pain management
number of physician visits for pain management
and use of medications for the treatment of drug-related adverse events.
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.
18 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 Chronic Pain, run by Purdue Pharma LP at 18 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 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 18 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?
Pilot study.. 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.