Back PainPhase 3BP96-0604NCT00315445
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
A Phase 3 study testing Buprenorphine transdermal patch and OXY/APAP in people with Back Pain, run by Purdue Pharma LP at 12 sites in United States.
Trial summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ 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
- Back Pain
- What is being tested?
- Buprenorphine transdermal patch and OXY/APAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 1997to May 1998
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.
Who cannot join
- receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
- scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Research Across America
Dallas, Texas, 75234
Metroplex Clinical Research Center
Dallas, Texas, 75235
Atlanta Research Center
Decatur, Georgia, 30033
Gainesville Clinical Research Center
Gainesville, Florida, 32605
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114
New Jersey Research Foundation
Linwood, New Jersey, 08221
SeaView Research
Miami, Florida, 33134
Phoenix Center for Clinical Research
Phoenix, Arizona, 85015
Phoenix Orthopedic Center, Ltd.
Phoenix, Arizona, 85023
Park Place Therapeutic Center
Plantation, Florida, 33324
North Carolina Clinical Research, Inc.
Raleigh, North Carolina, 27607
About this study
Official title: A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for 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.
- Conditions
- Back Pain
- Being tested
- Buprenorphine transdermal patch, Placebo oxycodone/acetaminophen tablets, OXY/APAP, Placebo transdermal patch (TDS)
- Keywords
- chronic back pain, opioid, transdermal
- Medical subject headings
- Back Pain
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 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
Placebo oxycodone/acetaminophen tabletsDrug
Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
OXY/APAPDrug
5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Placebo transdermal patch (TDS)Drug
Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20 Receives: Drug: Placebo oxycodone/acetaminophen tablets; Drug: Placebo transdermal patch (TDS) |
| OXY/APAP | Active comparator | 5 mg oxycodone/325 mg acetaminophen tablets Receives: Drug: OXY/APAP |
| BTDS | Experimental | Buprenorphine transdermal patch 5, 10, or 20 mcg/hour Receives: Drug: Buprenorphine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.
Measured: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Pain right now is presented as the LSmean [change from baseline] (SE).
Measured: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Secondary outcomes (14)
"Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)
The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. "Physical Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Measured: Day 84, or, if applicable, at early termination
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. "Physical Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Measured: Day 84
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Bodily Pain" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Measured: Day 84
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "General Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed.
Measured: Day 84
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Vitality" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Measured: Day 84
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Social Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
Measured: Day 84
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Emotional Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
Measured: Day 84
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Mental Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
Measured: Day 84
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
Measured: Day 84
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
Measured: Day 84
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = "Worse than prestudy medicine" to 2 = "Better than prestudy medicine."
Measured: Day 84
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
Measured: Day 84
Time to Stable Pain Management
For each subject, "time to stable pain management" is defined as the first (post-baseline) time during the titration period when his/her "diary pain" was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the "pain on the average" (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline).
Measured: Start of study to day 21.
The Time to Discontinuation Due to Lack of Efficacy
Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.
Measured: Time after dosing to dropout due to lack of efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startDec 1997
- Primary completionMay 1998
- Study completionMay 1998
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 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
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315445
- Sponsor's protocol ID
- BP96-0604
- Acronym
- BP96-0604
- Status last verified
- Aug 2012
- First submitted
- 17 Apr 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 Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00315445
- Acronym / sponsor ID
- BP96-0604 / BP96-0604
- Conditions
- Back Pain
- Keywords
- chronic back pain, opioid, transdermal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Dec 1997
- Primary completion
- May 1998 (actual)
- Study completion
- May 1998 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Posted 10 Aug 2011
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) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oxycodone/acetaminophen tablets, Drug: Placebo transdermal patch (TDS)Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20 |
| OXY/APAP | Active comparator | Drug: OXY/APAP5 mg oxycodone/325 mg acetaminophen tablets |
| BTDS | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch 5, 10, or 20 mcg/hour |
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 stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.
Key exclusion criteria (3 listed)
- receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
- scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.
- 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 patchAlso: Butrans™Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear. | Drug | BTDS |
| Placebo oxycodone/acetaminophen tabletsPlacebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. | Drug | Placebo |
| OXY/APAP5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. | Drug | OXY/APAP |
| Placebo transdermal patch (TDS)Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear | Drug | Placebo |
Primary outcome
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
Time frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
Time frame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Pain right now is presented as the LSmean [change from baseline] (SE).
14 secondary outcomes
"Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)
Time frame: Day 84, or, if applicable, at early termination
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
Time frame: Day 84
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
Time frame: Day 84
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time frame: Day 84
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time frame: Day 84
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time frame: Day 84
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time frame: Day 84
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
Time frame: Day 84
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
Time frame: Day 84
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
Time frame: Day 84
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
Time frame: Day 84
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
Time frame: Day 84
Time to Stable Pain Management
Time frame: Start of study to day 21.
The Time to Discontinuation Due to Lack of Efficacy
Time frame: Time after dosing to dropout due to lack of efficacy
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.
12 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 patch and OXY/APAP in people with Back Pain, run by Purdue Pharma LP at 12 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 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 12 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 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?
Yes. Results are posted in the registry (first posted 10 Aug 2011). 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?
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) (time frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.). 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 Sep 2012.