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

NCT02946073 | Completed Phase 3 Results

• 1 other identifier: HS-16-555
• Study Type: interventional
• Target: 1,053
• Locations: 1 country
• Sites: 69

Brief 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 (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.

Conditions

Chronic Lower Back Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks- from randomization baseline to 12 weeks after randomization

• 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.

  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)

• 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.

  12 weeks- from randomization baseline to 12 weeks after randomization

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

  12 weeks- from randomization baseline to 12 weeks after randomization

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

  12 weeks- from randomization baseline to 12 weeks after randomization

• 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.

  12 weeks- from randomization baseline to 12 weeks after randomization

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

  23 weeks- from baseline to 12 weeks after randomization

Study Arms (2)

Placebo

PLACEBO COMPARATOR

CAM2038 placebo injections

Other: Placebo

CAM2038

EXPERIMENTAL

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.

Drug: buprenorphine

Interventions

buprenorphine DRUG

Also known as: CAM2038

CAM2038

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Braeburn Pharmaceuticals: lead
• Medpace, Inc.: collaborator
• Camurus AB: collaborator

Study Sites (69)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Boyett Health Services Inc

Hamilton, Alabama, 35570, United States

Location

National Centers for Pain Management and Research

Vestavia Hills, Alabama, 35243, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Phoenix Clinical

Phoenix, Arizona, 85021, United States

Location

Noesis Pharma

Phoenix, Arizona, 85032, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

MD Studies, Inc.

Fountain Valley, California, 92708, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Allied Clinical Research, LLC

Sacramento, California, 95842, United States

Location

Care Practice

San Francisco, California, 94708, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Universal Pain Management Group

Valencia, California, 91355, United States

Location

Tampa Pain Relief Center-Brandon

Brandon, Florida, 33511, United States

Location

International Research Partners

Doral, Florida, 33122, United States

Location

Dr. Vijapura and Associates

Jacksonville, Florida, 32256, United States

Location

Florida Institute of Medical Research

Jacksonville, Florida, 32257, United States

Location

Lake Howell Health Center

Maitland, Florida, 32751, United States

Location

Ocean Blue Medical Research Center, Inc.

Miami Springs, Florida, 33166, United States

Location

Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Gold Coast Research, LLC

Plantation, Florida, 33317, United States

Location

FMPM Research

St. Petersburg, Florida, 33709, United States

Location

Clinical Research of West Florida-Tampa

Tampa, Florida, 33603, United States

Location

Tampa Pain Relief Centers-Hillsborough

Tampa, Florida, 33603, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

River Birch Research Alliance LLC

Blue Ridge, Georgia, 30513, United States

Location

Columbus Regional Research Institute

Knoxville, Georgia, 37909, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Non-Surgical Orthopedics, P.C.

Marietta, Georgia, 30060, United States

Location

Injury Care Research, LLC

Boise, Idaho, 83713, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Clinical Investigation Specialists, Inc.-Gurnee

Gurnee, Illinois, 60031, United States

Location

Medisphere Medical Research Center

Evansville, Indiana, 47714, United States

Location

International Clinical Research Institute Inc.

Overland Park, Kansas, 66210, United States

Location

Phoenix Medical Research

Prairie Village, Kansas, 66208, United States

Location

Otrimed

Edgewood, Kentucky, 41017, United States

Location

River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Boston Paincare

Waltham, Massachusetts, 02451, United States

Location

MedVadis Research Corporation

Watertown, Massachusetts, 02472, United States

Location

Amicis Trials

Festus, Missouri, 63028, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

New York Clinical Trials, Inc

New York, New York, 10022, United States

Location

MedEx Healthcare Research, Inc-NY

New York, New York, 10036, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Rapha Institute for Clinical Research

Fayetteville, North Carolina, 28314, United States

Location

OnSite Clinical Solutions, LLC-Hickory

Hickory, North Carolina, 28602, United States

Location

Center for Clinical Research, LLC-Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213, United States

Location

Dayton Outpatient Center (DOC) Clinical Research

Dayton, Ohio, 45432, United States

Location

Providence Health Partners-Center for Clinical Research

Dayton, Ohio, 45439, United States

Location

Medical Research Internationl

Oklahoma City, Oklahoma, 73109, United States

Location

SP Research, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

Frost Medical Group, LLC

Conshohocken, Pennsylvania, 19428, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Coastal Carolina Research Center

Charleston, South Carolina, 29406, United States

Location

Medical Research South, LLC

Charleston, South Carolina, 29407, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Renaissance Clinical Research and Hypertension Clinic

Dallas, Texas, 75234, United States

Location

Research Concepts GP, LLC-Houstion

Houston, Texas, 77004, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

The Pain Relief Center

Plano, Texas, 75024, United States

Location

The SMART Clinic/Physicians Research Options LLC

Draper, Utah, 84020, United States

Location

EPIC Medical Research

Murray, Utah, 84123, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Mid Columbia Research

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Susan Franks, SVP, Head of Regulatory Affaires
• Organization: Braeburn

sfranks@braeburnrx.com

6104678719

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: February 1, 2019
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (69)