PainPhase 3NCT01256450
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
A Phase 3 study testing Buprenorphine in people with Pain and Low Back Pain, run by BioDelivery Sciences International at 24 sites in United States.
Trial summary
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Low Back Pain
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 24 sitesUnited States
- Study dates
- Nov 2010to Jul 2011
- 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
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
- Written informed consent obtained at Screening, prior to any procedure being performed
Who cannot join
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome, or an immediate family member with this condition
- Diagnosis of moderate to severe hepatic impairment.
- History of severe emesis with opioids
- Clinically significant sleep apnea
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Allegheny Pain Management
Altoona, Pennsylvania, 16602
FutureSearch Trials of Neurology
Austin, Texas, 78731
Alabama Orthopaedic Center - Research
Birmingham, Alabama, 35209
Millennium Pain Center
Bloomington, Illinois, 61701
Avail Clinical Research, LLC
DeLand, Florida, 32720
Southwest Urgent Care Center
El Paso, Texas, 79902
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Neuro-Pain Medical Center
Fresno, California, 93710
Health Awareness, Inc.
Jupiter, Florida, 33458
University of California, San Diego Medical Center, UCSD Center for Pain Medicine
La Jolla, California, 92037
Office of Stephen H. Miller, MD
Las Vegas, Nevada, 89144
International Clinical Research Institute
Leawood, Kansas, 66211
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806
Taylor Research, LLC
Marietta, Georgia, 30060
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Research Across American
New York, New York, 10022
Arizona Research Center
Phoenix, Arizona, 85023
Gold Coast Research, LLC
Plantation, Florida, 33317
Accord Clinical Research, LLC
Port Orange, Florida, 32129
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Lifetree Clinical Research
Salt Lake City, Utah, 84106
MedVadis Research Corporation
Watertown, Massachusetts, 02472
Advanced Clinical Research
West Jordan, Utah, 84088
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
Read the detailed description
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.
Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.
- Conditions
- Pain, Low Back Pain
- Being tested
- Buprenorphine, Placebo
- Keywords
- buccal soluble film, enriched enrollment, randomized withdrawal
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called buprenorphine buccal soluble film, BEMA Buprenorphine, BELBUCA, buprenorphine HCl buccal film
buccal soluble film; applied to the buccal mucosa twice daily
PlaceboDrug
Also called Placebo buccal soluble film, Placebo buccal film, BEMA placebo
buccal soluble film; applied to the buccal mucosa twice daily
| Study group | Role | What they receive |
|---|---|---|
| BEMA Buprenorphine | Experimental | buprenorphine buccal soluble film Receives: Drug: Buprenorphine |
| BEMA Placebo | Placebo comparator | placebo buccal soluble film Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity From Baseline to Week 12
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, Week 12
Secondary outcomes (9)
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Week 12
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
Measured: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Measured: Baseline, Week 12
Use of Rescue Medication
Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
Measured: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Finn, PharmD, Study director, BioDelivery Sciences International, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256450
- Sponsor's protocol ID
- BUP-301
- Status last verified
- Jan 2017
- First submitted
- 7 Dec 2010
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01256450
- Acronym / sponsor ID
- BUP-301
- Conditions
- Pain, Low Back Pain
- Keywords
- buccal soluble film, enriched enrollment, randomized withdrawal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Posted 8 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
Detailed description
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.
Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEMA Buprenorphine | Experimental | Drug: Buprenorphinebuprenorphine buccal soluble film |
| BEMA Placebo | Placebo comparator | Drug: Placeboplacebo buccal soluble film |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
Key exclusion criteria (8 listed)
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome, or an immediate family member with this condition
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 |
|---|---|---|
| BuprenorphineAlso: buprenorphine buccal soluble film, BEMA Buprenorphine, BELBUCA, buprenorphine HCl buccal filmbuccal soluble film; applied to the buccal mucosa twice daily | Drug | BEMA Buprenorphine |
| PlaceboAlso: Placebo buccal soluble film, Placebo buccal film, BEMA placebobuccal soluble film; applied to the buccal mucosa twice daily | Drug | BEMA Placebo |
Primary outcome
Change in Pain Intensity From Baseline to Week 12
Time frame: Baseline, Week 12
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
9 secondary outcomes
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Time frame: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Time frame: Week 12
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Time frame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Time frame: Baseline, Week 12
Use of Rescue Medication
Time frame: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- 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.
Andrew Finn, PharmD study director
BioDelivery Sciences International, Inc.
24 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 in people with Pain and Low Back Pain, run by BioDelivery Sciences International at 24 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 6 inclusion and 8 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 8 Dec 2015). 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?
Change in Pain Intensity From Baseline to Week 12 (time frame: Baseline, Week 12). 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 27 Feb 2017.