PainPhase 3NCT01298765
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
A Phase 3 study testing BEMA Buprenorphine in people with Pain and Low Back Pain, run by BioDelivery Sciences International at 26 sites in United States.
Trial summary
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Low Back Pain, Osteoarthritis
- What is being tested?
- BEMA Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 26 sitesUnited States
- Study dates
- Mar 2011to Aug 2012
- 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 pain:
- Subjects completing study BUP-301 (low back pain) or
- Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and 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 prior to any procedure being performed
Who cannot join
- Cancer related pain
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
- History of severe emesis with opioids
- Clinically significant sleep apnea in the judgment of the investigator
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Altoona, Pennsylvania
Study site
Arcadia, California
Study site
Austin, Texas
Study site
Birmingham, Alabama
Study site
Bloomington, Illinois
Study site
DeLand, Florida
Study site
El Paso, Texas
Study site
Evansville, Indiana
Study site
Fresno, California
Study site
Jupiter, Florida
Study site
La Jolla, California
Study site
Las Vegas, Nevada
Study site
Leawood, Kansas
Study site
Long Beach, California
Study site
Marietta, Georgia
Study site
Mobile, Alabama
Study site
New York, New York
Study site
Phoenix, Arizona
Study site
Plantation, Florida
Study site
Port Orange, Florida
Study site
Raleigh, North Carolina
Study site
Salt Lake City, Utah
Study site
Watertown, Massachusetts
Study site
West Jordan, Utah
Study site
Westminster, Colorado
Study site
Winston-Salem, North Carolina
About this study
Official title: A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
Read the detailed description
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic pain.
BEMA Buprenorphine 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, Osteoarthritis, Neuropathic Pain
- Being tested
- BEMA Buprenorphine
- Keywords
- buccal soluble film
- Medical subject headings
- Pain, Low Back Pain, Osteoarthritis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEMA BuprenorphineDrug
Also called buprenorphine buccal soluble film
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: BEMA Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in NRS Pain Intensity
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.
Measured: Baseline up to approximately Week 52
Secondary outcomes (4)
Patient Global Impression of Change in Pain Intensity
Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'.
Measured: Baseline to Week 28
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items
Measured: Baseline to Week 28
Subjects Overall Satisfaction With Study Drug
Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.
Measured: Baseline to Week 52
Investigator's Overall Satisfaction With Study Drug
Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298765
- Sponsor's protocol ID
- BUP-305
- Status last verified
- Mar 2018
- First submitted
- 16 Feb 2011
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain
- ClinicalTrials.gov ID
- NCT01298765
- Acronym / sponsor ID
- BUP-305
- Conditions
- Pain, Low Back Pain, Osteoarthritis, Neuropathic Pain
- Keywords
- buccal soluble film
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 7 Aug 2018
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 BEMA Buprenorphine is safe in the treatment of chronic pain.
Detailed description
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic pain.
BEMA Buprenorphine 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEMA Buprenorphine | Experimental | Drug: BEMA Buprenorphinebuprenorphine 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 (7 listed)
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic pain:
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and 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 prior to any procedure being performed
Key exclusion criteria (5 listed)
- Cancer related pain
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
- History of severe emesis with opioids
- Clinically significant sleep apnea in the judgment of the investigator
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 |
|---|---|---|
| BEMA BuprenorphineAlso: buprenorphine buccal soluble filmbuccal soluble film; applied to the buccal mucosa twice daily | Drug | BEMA Buprenorphine |
Primary outcome
Change From Baseline in NRS Pain Intensity
Time frame: Baseline up to approximately Week 52
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.
4 secondary outcomes
Patient Global Impression of Change in Pain Intensity
Time frame: Baseline to Week 28
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Time frame: Baseline to Week 28
Subjects Overall Satisfaction With Study Drug
Time frame: Baseline to Week 52
Investigator's Overall Satisfaction With Study Drug
Time frame: Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- 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
26 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 BEMA Buprenorphine in people with Pain and Low Back Pain, run by BioDelivery Sciences International at 26 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 7 inclusion and 5 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Yes. Results are posted in the registry (first posted 7 Aug 2018). 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 From Baseline in NRS Pain Intensity (time frame: Baseline up to approximately Week 52). 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 7 Aug 2018.