Chronic Low Back PainPhase 3NCT00315887
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
A Phase 3 study testing Buprenorphine transdermal delivery system in people with Chronic Low Back Pain, 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 and hydrocodone/acetaminophen in subjects with chronic back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Buprenorphine transdermal delivery system
- How many people
- 250 participants
- Where
- 22 sitesUnited States
- Study dates
- Apr 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
- clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
- back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.
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 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
The Arthritis Clinic of Northern Virginia
Arlington, Virginia, 22206
Center for Clinical Research
Austin, Texas, 78758
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Riverhills Healthcare
Crestview Hills, Kentucky, 41017
University Clinical Research
DeLand, Florida, 32720
Evergreen Clinical Research
Edmonds, Washington, 98026
Gainesville Clinical Research Center
Gainesville, Florida, 32605
Cornerstone Research Care
High Point, North Carolina, 27262
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
Arthritis & Osteoporosis Treatment & Research Center
Jackson, Mississippi, 39216
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
PrecisionMed, Inc.
Las Vegas, Nevada, 89128
Miami Research Associates
Miami, Florida, 33173
Mid-America Rheumatology Consultants
Overland Park, Kansas, 66209
Arizona Research Center
Phoenix, Arizona, 85023
Sarasota Arthritis Center
Sarasota, Florida, 34239
Coastal Medical Research
South Daytona Beach, Florida, 32119
Pain Management & Rehabilitation
Terre Haute, Indiana, 47807
Arthritis Center of Connecticut
Waterbury, Connecticut, 06708
Private Practice
Wauwatosa, Wisconsin, 53226
Palm Beach Research Center
West Palm Beach, Florida, 33409
Private Practice
Weston, Florida, 33331
About this study
Official title: A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain
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 and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) 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 Low Back Pain
- Being tested
- Buprenorphine transdermal delivery system
- Keywords
- low back pain, opioid, transdermal
- Medical subject headings
- Low Back 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.
Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
Secondary outcomes (4)
Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
incidence of and time to early discontinuation due to lack of efficacy
investigator's assessment of therapeutic response
dose level at the end of titration
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 startApr 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 Chronic Low Back 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
- 250 participants
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315887
- Sponsor's protocol ID
- BP98-1201
- Status last verified
- Apr 2006
- First submitted
- 18 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 Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00315887
- Acronym / sponsor ID
- BP98-1201
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, opioid, transdermal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Study completion
- Oct 1999
- 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 and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) 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)
- clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
- back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.
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 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
Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
4 secondary outcomes
Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
incidence of and time to early discontinuation due to lack of efficacy
investigator's assessment of therapeutic response
dose level at the end of titration
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 Chronic Low Back Pain, 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?
Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.. 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.