Low Back PainPhase 3NCT01755546
Long-term Open-Label Safety Study to Evaluate EN3409
A Phase 3 study testing EN3409 in people with Low Back Pain and Osteoarthritis, run by BioDelivery Sciences International at 57 sites in United States.
Trial summary
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Osteoarthritis, Neuropathic Pain
- What is being tested?
- EN3409
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 57 sitesUnited States
- Study dates
- Dec 2012to Nov 2014
- 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
- Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
- Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
- De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
- De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
- Stable health, as determined by the Principal Investigator
- Subject is willing and able to comply with all protocol required visits and assessments
- Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study
Who cannot join
- A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Females who are pregnant, breastfeeding, or plan to become pregnant during the study
- Current cancer-related pain or received chemotherapy within 6 months of screening
- Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of screening
- De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per day within 28 days of screening
- Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
Show all 15Show fewer
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- History of allergy or contraindications to any opioid or acetaminophen
- Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28 days of screening
- Hypokalemia or clinically unstable cardiac disease
- Moderate to severe hepatic impairment
- Moderate to severe renal impairment
- Current or past history of alcohol or substance
- Positive urine toxicology screen for drugs of abuse
- History of abnormalities on physical exam, vital signs, ECG, or lab values
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Global Research, LLC
Anaheim, California, 92804
FutureSearch Clinical Trials
Austin, Texas, 78731
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Clinical Inquest Center, Ltd
Beavercreek, Ohio, 45432
The Center for Clinical Trials
Biloxi, Mississippi, 39531
Parkway Medical Center
Birmingham, Alabama, 35215
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513
Willis-Knighton Physician Network
Bossier City, Louisiana, 71111
Cadillac Clinical Research
Cadillac, Michigan, 49601
Pain Specialists of Charleston, P.A.
Charleston, South Carolina, 29406
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
KRK Medical Research
Dallas, Texas, 75230
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Century Clinical Research, Inc.
Daytona Beach, Florida, 32117
Avail Clinical Research, LLC
DeLand, Florida, 32720
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Synergy Clinical Research Center of Escondido
Escondido, California, 92025
Global Scientific Innovations
Evansville, Indiana, 47714
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104
Florida Health Center
Fort Lauderdale, Florida, 33312
Prestige Clinical Research
Franklin, Ohio, 45005
RX Clinical Research, Inc.
Garden Grove, California, 92843
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Eastern Research, Inc.
Hialeah, Florida, 33013
Advanced Clinical Research of Houston
Houston, Texas, 77062
Southeast Clinical Research, LLC
Jacksonville, Florida, 32216
Health Awareness, Inc.
Jupiter, Florida, 33458
Clinical Investigations Specialist, Inc.
Kenosha, Wisconsin, 53142
Long Beach Center for Clinical Research
Long Beach, California, 90807
Adam D. Karns, MD
Los Angeles, California, 90036
Drug Studies America
Marietta, Georgia, 30060
Taylor Research, LLC
Marietta, Georgia, 30060
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Horizon Research Group, Inc
Mobile, Alabama, 36608
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
In-Quest Medical Research, LLC
Norcross, Georgia, 30092
Research Centers of America, LLC
Oakland Park, Florida, 33334
Compass Research, LLC
Orlando, Florida, 32806
Ribo Research LLC DBA Peninsula Research
Ormond Beach, Florida, 32806
Arizona Research Center
Phoenix, Arizona, 85023
Gold Coast Research, LLC
Plantation, Florida, 33317
Progressive Medical Research
Port Orange, Florida, 32127
Health Concepts
Rapid City, South Dakota, 57702
Highland Clinical Research
Salt Lake City, Utah, 84124
Innovative Clinical Trials
San Antonio, Texas, 78229
River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Optimed Research, Ltd.
Tiffin, Ohio, 44883
Integrated Clinical Trials Services, Inc.
West Des Moines, Iowa, 50265
Palm Beach Research Center
West Palm Beach, Florida, 33409
Upstate Clinical Research Associates
Williamsville, New York, 14221
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
National Pain Research Institute, LLC
Winter Park, Florida, 32789
About this study
Official title: A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
- Conditions
- Low Back Pain, Osteoarthritis, Neuropathic Pain
- Being tested
- EN3409
- Keywords
- Chronic Pain, CLBP, Chronic Low Back Pain, Back Pain, Osteoarthritis, OA, Neuropathic Pain, Nerve pain, Painful neuropathy
- Medical subject headings
- Low Back Pain, Osteoarthritis, Neuralgia, Chronic Pain, Back Pain, Neuropathy, Painful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3409Drug
Also called Buprenorphine HCI Buccal Film 300-900 mcg twice daily
Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily
| Study group | Role | What they receive |
|---|---|---|
| EN3409 | Experimental | Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily Receives: Drug: EN3409 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
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 the change from baseline at week 48 is presented.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2014
- Study completionNov 2014
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 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, BioDelivary Sciences Internantional, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755546
- Sponsor's protocol ID
- EN3409-309
- Status last verified
- Mar 2018
- First submitted
- 19 Dec 2012
- Last updated
- 18 Oct 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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time
- ClinicalTrials.gov ID
- NCT01755546
- Acronym / sponsor ID
- EN3409-309
- Conditions
- Low Back Pain, Osteoarthritis, Neuropathic Pain
- Keywords
- Chronic Pain, CLBP, Chronic Low Back Pain, Back Pain, Osteoarthritis, OA, Neuropathic Pain, Nerve pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Posted 12 Sep 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 the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EN3409 | Experimental | Drug: EN3409Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
- Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
- De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
- De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
- Stable health, as determined by the Principal Investigator
Key exclusion criteria (15 listed)
- A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Females who are pregnant, breastfeeding, or plan to become pregnant during the study
- Current cancer-related pain or received chemotherapy within 6 months of screening
- Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of screening
- De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per day within 28 days of screening
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 |
|---|---|---|
| EN3409Also: Buprenorphine HCI Buccal Film 300-900 mcg twice dailyOpen-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily | Drug | EN3409 |
Primary outcome
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
Time frame: 48 weeks
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 the change from baseline at week 48 is presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 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
BioDelivary Sciences Internantional, Inc.
57 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 EN3409 in people with Low Back Pain and Osteoarthritis, run by BioDelivery Sciences International at 57 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 15 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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 12 Sep 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 to Week 48 in Daily Average NRS Pain Intensity Score (time frame: 48 weeks). 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 18 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.