Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
NCT ID: NCT02946073
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1053 participants
INTERVENTIONAL
2016-09-30
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
CAM2038 placebo injections
Placebo
CAM2038
CAM2038 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.
buprenorphine
Interventions
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buprenorphine
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant, non-lactating female subject, greater than or equal to 18 years old.
3. Body mass index (BMI) between 18 and 38 kg/m2, inclusive.
4. Treated with daily opioids for moderate to severe CLBP for a minimum of 3 months prior to Screening.
5. On a stable dose of ≥40 mg/day of oral morphine or MED during the 14 days prior to Screening.
6. Systolic blood pressure ≥100 mmHg and diastolic blood pressure ≥60 mmHg.
7. 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).
8. Male subject who is willing to use reliable contraception
9. Willing and able to comply with all study procedures and requirements.
Subjects must have:
1. Completed Double Blind Phase of the study
2. 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)
1. Written informed consent provided prior to the conduct of any study-related procedures.
2. Male or non-pregnant and non-lactating female subject, greater than or equal to 18 years old.
3. BMI between 18 and 38 kg/m2, inclusive.
4. 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.
5. On a stable dose of \>40 mg/day of oral morphine or MED during the 14 days prior to Screening.
6. Systolic blood pressure ≥100 mmHg and diastolic blood pressure ≥60 mmHg.
7. 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).
8. Male subject who is willing to use reliable contraception
9. Willing and able to comply with all study procedures and requirements.
Exclusion Criteria
2. 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:
1. Severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, biliary tract disease, severe hepatic insufficiency, or planned surgery.
2. Bipolar disorder
3. 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.
4. Female subject planning to become pregnant during the study.
5. Surgical procedure(s) for CLBP within 6 months prior to Screening.
6. 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.
7. QTcF \>450 ms for males and \>470 ms for females, or clinically significant electrocardiogram (ECG) abnormality at Screening, at the investigator's discretion.
8. 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.
9. 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.
10. History of chemotherapy or confirmed malignancy (except basal cell carcinoma) within the past 2 years.
11. 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.
12. An active or pending workman's compensation, insurance claim, or litigation related to back pain (i.e., primary claim is back pain).
13. Clinically significant history, in the opinion of the investigator, of suicidal ideation or current evidence that the subject is actively suicidal.
14. Clinically significant history of major depressive disorder that is poorly controlled with medication, per investigator judgment.
15. Hypersensitivity or allergy to BPN, other opioids, or excipients of CAM2038.
16. Hypersensitivity or allergy to acetaminophen.
17. 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,
18. Use or planned use of natural supplements that can affect CYP3A4, such as St. John's Wort, throughout the study.
19. Has a major bleeding disorder, such as hemophilia, or treated with high levels of anticoagulants per the investigator's discretion.
20. Current or confirmed past diagnosis of Sphincter of Oddi dysfunction.
21. 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).
22. 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.
23. Has any pending legal action that could prohibit participation or compliance in the study.
Criteria for Entry into the Titration Phase:
1. 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.
2. 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:
1. Been on a stable dose of CAM2038 q1w for at least 2 consecutive weeks.
2. 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.
3. Requires no more than an average of one hydrocodone/acetaminophen 5 mg/325 mg/day during the last 7 days prior to randomization.
4. Demonstrated study medication (CAM2038) compliance ≥80% during the previous 14 days.
5. Demonstrated daily compliance with pain intensity scoring for ≥11 of the previous 14 days, including the last 3 days prior to randomization.
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.
Criteria for Entry into the Titration Phase (for De novo subjects):
1. 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.
2. 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):
1. Been on a stable dose of CAM2038 q1w for at least 2 consecutive weeks.
2. 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.
3. Requires no more than an average of one hydrocodone/acetaminophen 5 mg/325 mg/day during the last 7 days prior to randomization
18 Years
75 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Camurus AB
INDUSTRY
Braeburn Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Parkway Medical Center
Birmingham, Alabama, United States
Boyett Health Services Inc
Hamilton, Alabama, United States
National Centers for Pain Management and Research
Vestavia Hills, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Phoenix Clinical
Phoenix, Arizona, United States
Noesis Pharma
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
MD Studies, Inc.
Fountain Valley, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Alliance Research Centers
Laguna Hills, California, United States
Clinical Trials Research
Lincoln, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Allied Clinical Research, LLC
Sacramento, California, United States
Care Practice
San Francisco, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Universal Pain Management Group
Valencia, California, United States
Tampa Pain Relief Center-Brandon
Brandon, Florida, United States
International Research Partners
Doral, Florida, United States
Dr. Vijapura and Associates
Jacksonville, Florida, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Lake Howell Health Center
Maitland, Florida, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Gold Coast Research, LLC
Plantation, Florida, United States
FMPM Research
St. Petersburg, Florida, United States
Clinical Research of West Florida-Tampa
Tampa, Florida, United States
Tampa Pain Relief Centers-Hillsborough
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
River Birch Research Alliance LLC
Blue Ridge, Georgia, United States
Columbus Regional Research Institute
Knoxville, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Non-Surgical Orthopedics, P.C.
Marietta, Georgia, United States
Injury Care Research, LLC
Boise, Idaho, United States
Millennium Pain Center
Bloomington, Illinois, United States
Clinical Investigation Specialists, Inc.-Gurnee
Gurnee, Illinois, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
International Clinical Research Institute Inc.
Overland Park, Kansas, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Otrimed
Edgewood, Kentucky, United States
River Cities Clinical Research Center
Shreveport, Louisiana, United States
Boston Paincare
Waltham, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Amicis Trials
Festus, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
New York Clinical Trials, Inc
New York, New York, United States
MedEx Healthcare Research, Inc-NY
New York, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Rapha Institute for Clinical Research
Fayetteville, North Carolina, United States
OnSite Clinical Solutions, LLC-Hickory
Hickory, North Carolina, United States
Center for Clinical Research, LLC-Winston-Salem
Winston-Salem, North Carolina, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Dayton Outpatient Center (DOC) Clinical Research
Dayton, Ohio, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States
Medical Research Internationl
Oklahoma City, Oklahoma, United States
SP Research, PLLC
Oklahoma City, Oklahoma, United States
Frost Medical Group, LLC
Conshohocken, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Coastal Carolina Research Center
Charleston, South Carolina, United States
Medical Research South, LLC
Charleston, South Carolina, United States
New Phase Research & Development
Knoxville, Tennessee, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, United States
Research Concepts GP, LLC-Houstion
Houston, Texas, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
The Pain Relief Center
Plano, Texas, United States
The SMART Clinic/Physicians Research Options LLC
Draper, Utah, United States
EPIC Medical Research
Murray, Utah, United States
Aspen Clinical Research
Orem, Utah, United States
Mid Columbia Research
Richland, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HS-16-555
Identifier Type: -
Identifier Source: org_study_id