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Low Back PainPhase 3NCT01633944

Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

A Phase 3 study testing Buprenorphine in people with Low Back Pain, run by BioDelivery Sciences International at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief 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
What is being tested?
Buprenorphine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
752 participants
Where
60 sitesUnited States
Study dates
Aug 2012to Dec 2013
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

  • Diagnosis of moderate to severe low back pain for ≥6 months
  • Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
  • Stable health, as determined by Principal Investigator
  • Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
  • Willing and able to comply with all protocol required visits and assessments

Who cannot join

  • Current cancer related pain or received chemotherapy with 6 months of screening
  • Receiving opioid analgesic medication >10 mg MSE per day within 28 days of screening
  • Subjects with a history of other chronic painful conditions
  • Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
  • Allergy or contraindications to any opioid or acetaminophen
  • Surgical procedure for relief of pain with 6 months
Show all 14Show fewer
  • Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
  • QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
  • History of long QT syndrome or a family member with this condition
  • Moderate to severe hepatic impairment
  • Moderate to severe renal impairment
  • Current or past history of alcohol abuse
  • Positive urine toxicology screen for drug of abuse
  • History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Global Research

    Anaheim, California, 92804

  • Atlanta Research Center

    Atlanta, Georgia, 30319

  • FutureSearch Clinical Trials - Austin

    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

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • Willis-Kinghton Physician Network/River Interventional Pain Specialist

    Bossier City, Louisiana, 71111

  • Catalina Research Institute, LLC

    Chino, California, 91710

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida - Clearwater

    Clearwater, Florida, 33765

  • Optimed Research, Ltd.

    Columbus, Ohio, 43235

  • 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

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Plains Medical Clinic, LLC

    Fargo, North Dakota, 58104

  • Florida Health Center

    Fort Lauderdale, Florida, 33312

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • PharmQuest, LLC

    Greensboro, North Carolina, 27408

  • Eastern Research, Inc.

    Hialeah, Florida, 33013

  • Advanced Clinical Research of Houston

    Houston, Texas, 77062

  • Clinical Trial Network

    Houston, Texas, 77074

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Drug Study Institute

    Jupiter, Florida, 33458

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Clinical Investigations Specialists, Inc.

    Kenosha, Wisconsin, 53142

  • Office of Robert Kaplan, DO

    Las Vegas, Nevada, 89119

  • Adam D. Karns MD

    Los Angeles, California, 90036

  • Drug Studies America

    Marietta, Georgia, 30060

  • Georgia Institute for Clinical Research, LLC

    Marietta, Georgia, 30060

  • Taylor Research, LLC

    Marietta, Georgia, 30060

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Horizon Research Group, Inc./Alabama Orthopedic Clinic

    Mobile, Alabama, 36608

  • NEMA Research, Inc.

    Naples, Florida, 34108

  • Best Clinical Trials, Inc.

    New Orleans, Louisiana, 70115

  • Health Research Institute

    Oklahoma City, Oklahoma, 73109

  • NPC Research

    Oklahoma City, Oklahoma, 73109

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Peninsula Research

    Ormond Beach, Florida, 32174

  • International Clinical Research Institute, Inc.

    Overland Park, Kansas, 66210

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Gold Coast Research, L.L.C.

    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 - Tampa

    Tampa, Florida, 33603

  • MedVadis Research Corp.

    Watertown, Massachusetts, 02472

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • National Pain Research Institute, LLC

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

Conditions
Low Back Pain
Being tested
Buprenorphine, Placebo
Keywords
CLBP, Chronic Low Back Pain, Chronic Pain, Back Pain
Medical subject headings
Low Back Pain, Chronic Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuprenorphineDrug

    Also called BELBUCA, Buprenorphine HCl Buccal Film, BEMA Buprenorphine, EN3409

    Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily

  • PlaceboDrug

    Also called Placebo Buccal Film, BEMA Placebo

    Matching Placebo Buccal Film twice daily

Study groups in NCT01633944
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwice Daily Dosing
Receives: Drug: Placebo
Buprenorphine HCl Buccal FilmExperimentalTwice Daily Dosing
Receives: Drug: Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in Average Daily Pain Intensity Scores

    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 (7)

  1. Number of Participants With Response to Treatment (Responder) Using NRS Scale

    Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).

    Measured: Prior to open-label titration to Week 12 in double-blind treatment

  2. Number of Subjects With Rescue Medication Use

    Use of analgesic rescue medication recorded in subject diary.

    Measured: Week 1 to Week 12 in double-blind treatment

  3. Time to Optimal Dose of Open-label Study Medication

    Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment.

    Measured: Up to 8 weeks in open-label titration

  4. 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 discontinuation due to adverse events in the double-blind treatment phase.

    Measured: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)

  5. Patient Global Impression of Change

    Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)

    Measured: Week 12

  6. 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

  7. Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale

    Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633944
Sponsor's protocol ID
EN3409-308
Status last verified
Jan 2017
First submitted
2 Jul 2012
Last updated
27 Feb 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Buprenorphine in people with Low Back Pain, run by BioDelivery Sciences International at 60 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 5 inclusion and 14 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 60 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 3 Feb 2016). 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 12 in Average Daily Pain Intensity Scores (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?

On the ClinicalTrials.gov record for NCT01633944.

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.

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