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Chronic Lower Back PainPhase 3CAM2038NCT02946073

Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain

A Phase 3 study testing buprenorphine in people with Chronic Lower Back Pain and Chronic Pain, run by Braeburn Pharmaceuticals at 69 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

This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that requires continuous, around-the-clock (ATC) opioid treatment ≥ 40 mg morphine equivalent dose… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Lower Back Pain, Chronic Pain
What is being tested?
buprenorphine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,053 participants
Where
69 sitesUnited States
Study dates
Sep 2016to Feb 2019
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent provided prior to the conduct of any study-related procedures.
  • Male or non-pregnant, non-lactating female subject, greater than or equal to 18 years old.
  • Body mass index (BMI) between 18 and 38 kg/m2, inclusive.
  • Treated with daily opioids for moderate to severe CLBP for a minimum of 3 months prior to Screening.
  • On a stable dose of ≥40 mg/day of oral morphine or MED during the 14 days prior to Screening.
  • Systolic blood pressure ≥100 mmHg and diastolic blood pressure ≥60 mmHg.
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  • Female subject of childbearing potential who is willing to use a reliable method of contraception during the entire study (Screening Visit to final Follow-up). To be considered not of childbearing potential, female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy, or bilateral tubal ligation with surgery at least 6 weeks before Screening).
  • Male subject who is willing to use reliable contraception
  • Willing and able to comply with all study procedures and requirements.

Who cannot join

  • Positive for hepatitis B surface antigen, hepatitis C viral RNA, or antibodies to human immunodeficiency virus (HIV).
  • Clinically significant symptoms, medical conditions, or other circumstances which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent, or may prevent the subject from safely participating in the study, including the following:
  • Severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, biliary tract disease, severe hepatic insufficiency, or planned surgery.
  • Bipolar disorder
  • Current diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-defined moderate to severe substance use disorder (including alcohol), other than caffeine or nicotine.
  • Female subject planning to become pregnant during the study.
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  • Surgical procedure(s) for CLBP within 6 months prior to Screening.
  • Concomitant disease(s) that could prolong the QTcF interval, such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, Long QT Syndrome, or family history of Long QT Syndrome.
  • QTcF >450 ms for males and >470 ms for females, or clinically significant electrocardiogram (ECG) abnormality at Screening, at the investigator's discretion.
  • Currently taking medications that have the potential to prolong the QTcF interval or may require such medications during the course of the study (Appendix 1) and has clinically significant abnormalities on screening ECG readings, as determined by the investigator.
  • A nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to Screening or botulinum toxin injection in the lower back region within 3 months of Screening.
  • History of chemotherapy or confirmed malignancy (except basal cell carcinoma) within the past 2 years.
  • Any other acute or chronic pain condition that could interfere with the subject's ability to report their CLBP accurately and consistently and/or interfere with the study staff's ability to assess the subjects CLBP.
  • An active or pending workman's compensation, insurance claim, or litigation related to back pain (i.e., primary claim is back pain).
  • Clinically significant history, in the opinion of the investigator, of suicidal ideation or current evidence that the subject is actively suicidal.
  • Clinically significant history of major depressive disorder that is poorly controlled with medication, per investigator judgment.
  • Hypersensitivity or allergy to BPN, other opioids, or excipients of CAM2038.
  • Hypersensitivity or allergy to acetaminophen.
  • Use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4), such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) within the 30 days prior to Screening,
  • Use or planned use of natural supplements that can affect CYP3A4, such as St. John's Wort, throughout the study.
  • Has a major bleeding disorder, such as hemophilia, or treated with high levels of anticoagulants per the investigator's discretion.
  • Current or confirmed past diagnosis of Sphincter of Oddi dysfunction.
  • Has a significant hepatic disease, as indicated by Screening clinical laboratory assessment results (aspartate aminotransferase, alanine aminotransferase, or lactate dehydrogenase values ≥3 × the upper limit of normal [ULN]) or has a creatinine value ≥1.5 × ULN).
  • Is an employee of the investigator or the trial site, with direct involvement in the proposed trial or other studies under the direction of the investigator or trial site or is a family member of the investigator or of an employee of the investigator.
  • Has any pending legal action that could prohibit participation or compliance in the study.
  • Criteria for Entry into the Titration Phase:
  • After at least a 12-hour washout from the last IR morphine dose, subject must have a COWS ≥5 and an API pain score over the past 24 hours ≥5 in order to receive a test dose of Buprenex.
  • Passed all baseline criteria, including a normal QTcF, had no change in QTcF >30 ms at 1 hour after the test dose with Buprenex, and had a COWS score <5 after the test dose with Buprenex.
  • Note:
  • Subjects on BPN at Screening are required to participate in the down titration and will undergo a washout period prior to the test dose and first on-study treatment. Subjects entering the study on BPN will not transition to IR Morphine, but will refrain from taking their BPN for 12 -24 hours prior to the test dose to achieve the desired washout period.
  • Subjects on BPN at Screening are still required to follow the same Day 1 procedures (e.g., confirmation of pain scores, COWS assessment and Buprenex test dose) as non-BPN subjects.
  • Criteria for Randomization into the Double-Blind Phase:
  • Been on a stable dose of CAM2038 q1w for at least 2 consecutive weeks.
  • CAM2038 titrated to a dose that provides analgesia (i.e., 7-day API score of ≤4 and at least 2 points below the value at the start of Titration Phase) and is well tolerated for 7 days before randomization.
  • Requires no more than an average of one hydrocodone/acetaminophen 5 mg/325 mg/day during the last 7 days prior to randomization.
  • Demonstrated study medication (CAM2038) compliance ≥80% during the previous 14 days.
  • Demonstrated daily compliance with pain intensity scoring for ≥11 of the previous 14 days, including the last 3 days prior to randomization.
  • Inclusion Criteria for Open Label Extension For Subjects Continuing from The Randomized Double-Blind Phase.
  • Subjects must have:
  • Completed Double Blind Phase of the study
  • Signed Informed Consent for Safety Extension
  • Subjects completing the double-blind phase will be enrolled directly into the open label extension at their respective dose level of CAM2038. They will not be required to participate in a Buprenex treatment test dosing or participate in a titration phase.
  • For De Novo Subjects (New Subjects Recruited Directly into The Open Label Extension)
  • Subjects who are not participating in the Double-Blind Phase of the Study must meet all of the following inclusion criteria in order to be eligible for participation in the study:
  • Written informed consent provided prior to the conduct of any study-related procedures.
  • Male or non-pregnant and non-lactating female subject, greater than or equal to 18 years old.
  • BMI between 18 and 38 kg/m2, inclusive.
  • Treated with daily opioids for moderate to severe chronic pain disorder such as CLBP or osteoarthritis for a minimum of 3 months prior to Screening.
  • On a stable dose of >40 mg/day of oral morphine or MED during the 14 days prior to Screening.
  • Systolic blood pressure ≥100 mmHg and diastolic blood pressure ≥60 mmHg.
  • Female subject of childbearing potential who is willing to use a reliable method of contraception during the entire study (Screening Visit to final Follow-up). To be considered not of childbearing potential, female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy, or bilateral tubal ligation with surgery at least 6 weeks before Screening).
  • Male subject who is willing to use reliable contraception
  • Willing and able to comply with all study procedures and requirements.
  • Exclusion Criteria for Subjects Continuing from The Randomized Double-Blind Phase
  • 1. Clinically significant symptoms, medical conditions, or other circumstances which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent, or may prevent the subject from safely participating in the study.
  • Same exclusion criteria as for subjects participating in the Randomized Double-Blind Treatment Phase.
  • Criteria for Entry into the Titration Phase (for De novo subjects):
  • After at least a 12-hour washout from the last IR morphine dose, subject should have a COWS ≥5 and an API pain score over the past 24 hours ≥5 in order to receive a test dose of Buprenex.
  • Passed all baseline criteria, including a normal QTcF, had no change in QTcF >30 ms at 1 hour after the test dose with Buprenex, and had a COWS score <5 after the test dose with Buprenex.
  • Note:
  • Subjects on BPN at Screening are required to participate in the down titration and will undergo a washout period prior to the test dose and first on-study treatment. Subjects entering the study on BPN will not transition to IR Morphine, but will refrain from taking their BPN for 12 -24 hours prior to the test dose to achieve the desired washout period.
  • However, subjects on BPN at Screening are still required to follow the same Day 1 procedures (e.g., confirmation of pain scores, COWS assessment and Buprenex test dose) as non-BPN subjects.
  • Criteria for Enrolment into the Open Label Treatment Phase (for de Novo subjects):
  • Been on a stable dose of CAM2038 q1w for at least 2 consecutive weeks.
  • CAM2038 titrated to a dose that provides analgesia (i.e., 7-day API score of ≤4 and at least 2 points below the value at the start of Titration Phase) and is well tolerated for 7 days before randomization.
  • Requires no more than an average of one hydrocodone/acetaminophen 5 mg/325 mg/day during the last 7 days prior to randomization

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Millennium Pain Center

    Bloomington, Illinois, 61701

  • River Birch Research Alliance LLC

    Blue Ridge, Georgia, 30513

  • Injury Care Research, LLC

    Boise, Idaho, 83713

  • Tampa Pain Relief Center-Brandon

    Brandon, Florida, 33511

  • Coastal Carolina Research Center

    Charleston, South Carolina, 29406

  • Medical Research South, LLC

    Charleston, South Carolina, 29407

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213

  • Frost Medical Group, LLC

    Conshohocken, Pennsylvania, 19428

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Renaissance Clinical Research and Hypertension Clinic

    Dallas, Texas, 75234

  • Dayton Outpatient Center (DOC) Clinical Research

    Dayton, Ohio, 45432

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio, 45439

  • International Research Partners

    Doral, Florida, 33122

  • The SMART Clinic/Physicians Research Options LLC

    Draper, Utah, 84020

  • Otrimed

    Edgewood, Kentucky, 41017

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Rapha Institute for Clinical Research

    Fayetteville, North Carolina, 28314

  • Amicis Trials

    Festus, Missouri, 63028

  • MD Studies, Inc.

    Fountain Valley, California, 92708

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Clinical Investigation Specialists, Inc.-Gurnee

    Gurnee, Illinois, 60031

  • Boyett Health Services Inc

    Hamilton, Alabama, 35570

  • OnSite Clinical Solutions, LLC-Hickory

    Hickory, North Carolina, 28602

  • Research Concepts GP, LLC-Houstion

    Houston, Texas, 77004

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099

  • Dr. Vijapura and Associates

    Jacksonville, Florida, 32256

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Columbus Regional Research Institute

    Knoxville, Georgia, 37909

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Clinical Trials Research

    Lincoln, California, 95648

  • Lake Howell Health Center

    Maitland, Florida, 32751

  • Drug Studies America

    Marietta, Georgia, 30060

  • Non-Surgical Orthopedics, P.C.

    Marietta, Georgia, 30060

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Ocean Blue Medical Research Center, Inc.

    Miami Springs, Florida, 33166

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • EPIC Medical Research

    Murray, Utah, 84123

  • New York Clinical Trials, Inc

    New York, New York, 10022

  • MedEx Healthcare Research, Inc-NY

    New York, New York, 10036

  • Scientific Clinical Research, Inc.

    North Miami, Florida, 33161

  • Medical Research Internationl

    Oklahoma City, Oklahoma, 73109

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112

  • Aspen Clinical Research

    Orem, Utah, 84058

  • International Clinical Research Institute Inc.

    Overland Park, Kansas, 66210

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Phoenix Clinical

    Phoenix, Arizona, 85021

  • Noesis Pharma

    Phoenix, Arizona, 85032

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • The Pain Relief Center

    Plano, Texas, 75024

  • Gold Coast Research, LLC

    Plantation, Florida, 33317

  • Phoenix Medical Research

    Prairie Village, Kansas, 66208

  • Mid Columbia Research

    Richland, Washington, 99352

  • Allied Clinical Research, LLC

    Sacramento, California, 95842

  • Care Practice

    San Francisco, California, 94708

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • River Cities Clinical Research Center

    Shreveport, Louisiana, 71105

  • FMPM Research

    St. Petersburg, Florida, 33709

  • Clinical Research of West Florida-Tampa

    Tampa, Florida, 33603

  • Tampa Pain Relief Centers-Hillsborough

    Tampa, Florida, 33603

  • Universal Pain Management Group

    Valencia, California, 91355

  • National Centers for Pain Management and Research

    Vestavia Hills, Alabama, 35243

  • Boston Paincare

    Waltham, Massachusetts, 02451

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • Center for Clinical Research, LLC-Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects With Moderate to Severe Chronic Low Back Pain Currently Treated With Daily Opioids

This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that requires continuous, around-the-clock (ATC) opioid treatment ≥ 40 mg morphine equivalent dose (MED). The study includes 5 phases: A Screening Phase (up to 2 weeks), a Transition Phase (up to 2 weeks), an Open-Label Titration Phase (up to 10 weeks), a Double-Blind Treatment Phase including a Final Study Visit (12 weeks), and a Follow-up Phase (4 weeks). The overall duration of participation in the core phase of the study (randomized Double-Blind Phase) is up to 30 weeks, from the Screening Phase through the Follow-up Phase. Subjects who complete the Double-Blind Treatment Study Phase will be offered an opportunity to continue treatment in an open label safety extension for up to 60 weeks. Additional subjects may be recruited to open label safety extension to meet the goal of 100 subjects with 60 weeks of treatment.

Being tested
buprenorphine, Placebo
Medical subject headings
Chronic Pain

What participants receive

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

Study groups in NCT02946073
Study groupRoleWhat they receive
PlaceboPlacebo comparatorCAM2038 placebo injections
Receives: Other: Placebo
CAM2038ExperimentalCAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, 16 mg, 24 mg, or 32 mg. CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg.
Receives: Drug: buprenorphine

What is being measured

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

  1. Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase.

    Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain.

    Measured: 12 weeks- from randomization baseline to 12 weeks after randomization

  2. Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.

    Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

Secondary outcomes (15)

  1. Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain.

    Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain.

    Measured: 12 weeks- from randomization baseline to 12 weeks after randomization

  2. Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase.

    Number of Responders With a 30% and 50% Reduction in WAAPI from the Open-Label Titration Period Baseline to Week 12 of the Double-Blind Treatment Period (mITT Population)

    Measured: 12 weeks- from randomization baseline to 12 weeks after randomization

  3. Summary of Rescue Medication Usage- Double-Blind Phase.

    Rescue medication usage (number of days used) during the Double-Blind Phase.

    Measured: 12 weeks- from randomization baseline to 12 weeks after randomization

  4. Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score.

    Change from Open Label Titration baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level self-report questionnaire score. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health.

    Measured: 12 weeks- from randomization baseline to 12 weeks after randomization

  5. Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score

    Change from baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment score. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed)，Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)，and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment.

    Measured: 23 weeks- from baseline to 12 weeks after randomization

  6. Number of Subjects Discontinued Due to Loss of Efficacy

    Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy.

    Measured: 12 weeks- from randomization baseline to 12 weeks after randomization

  7. Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale

    Change from baseline to Week 12 of the Double-Blind Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I)Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study at the beginning of the intervention . Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better

    Measured: 12 weeks- from baseline (randomization) to 12 weeks after randomization

  8. Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.

    Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 52 of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  9. Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy.

    Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy Open Label Phase.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  10. Summary of Rescue Medication Usage-Open Label Phase

    Rescue medication usage (number of days used) during the Open Label Phase.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  11. Summary of Change From Baseline in EuroQoL Group EQ-5D-5L Scores Over Time-Open Label Phase

    Change from Open Label Titration baseline in EuroQol Group 5-dimension 5-level self-report questionnaire score in the Open Label Phase. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  12. Summary of Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale-Open Label

    Summary of Change from Baseline in Clinical Global Impression of Improvement (CGI-I) scale. The Clinician Global Impression of Improvement (CGI-I) Scale is a 7-point scale that required the clinician to assess how much the subject's Pain had improved or worsened relative to the start of the study. Assessments were rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  13. Summary of Change From Baseline in Patient Global Impression of Improvement (PGI-I) Scale

    Change from baseline in the Open Label Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study. Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  14. Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase

    Change from baseline in the Open Label Phase in Work Productivity and Activity Impairment score with a range of 0-100 for 4 types of scores with higher scores indicating greater impairment. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed)，Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)，and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

  15. Number of Subjects Discontinued Due to Loss of Efficacy

    Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy.

    Measured: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).

Timeline

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

  1. First posted26 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionMay 2018
  4. Study completionFeb 2019

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946073
Sponsor's protocol ID
HS-16-555
Acronym
CAM2038
Status last verified
Jan 2021
First submitted
7 Oct 2016
Last updated
15 Oct 2021
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing buprenorphine in people with Chronic Lower Back Pain and Chronic Pain, run by Braeburn Pharmaceuticals at 69 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 9 inclusion and 66 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 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 15 Oct 2021). 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 Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. (time frame: 12 weeks- from randomization baseline to 12 weeks after randomization). 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?

On the ClinicalTrials.gov record for NCT02946073.

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 15 Oct 2021.

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