Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain
Randomized Placebo-controlled Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Chronic Low Back Pain
2 other identifiers
interventional
159
2 countries
31
Brief Summary
The purpose of this study is to test whether LY3526318 is efficacious and safe in relieving chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 20, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2022
CompletedResults Posted
Study results publicly available
October 5, 2023
CompletedOctober 5, 2023
October 1, 2023
8 months
October 19, 2021
June 9, 2023
October 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Baseline, Week 4
Secondary Outcomes (15)
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)
Baseline, Week 4
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)
Baseline, Week 8
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Baseline, Week 4
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Baseline, Week 8
- +10 more secondary outcomes
Study Arms (2)
LY3526318
EXPERIMENTALParticipants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.
Placebo
PLACEBO COMPARATORParticipants received placebo orally, once daily, for 8-weeks treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
- Have a history of daily pain for at least 12 weeks based on participant report or medical history.
- Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive).
- Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
- Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
- Are at 18 years old or older at the time consent is signed.
- Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.
- Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
- Are men, or women able to abide by reproductive and contraceptive requirements.
You may not qualify if:
- Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
- Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
- Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- Have fibromyalgia
- Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- Have a positive human immunodeficiency virus (HIV) test result at screening.
- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- Have an intolerance to acetaminophen or paracetamol or any of its excipients.
- Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
- Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
- Have history of or current compression fracture.
- Have had a recent major trauma (within 6 months of baseline).
- Have a history of low back pain as classified by the Quebec Task Force categories 4 through 11.
- Are using a spinal cord stimulator or dorsal root ganglion stimulator.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Synexus- Chandler
Chandler, Arizona, 85224, United States
Synexus Clinical Research - Glendale
Glendale, Arizona, 85306, United States
Alliance for Multispecialty Research, LLC Tempe
Tempe, Arizona, 85281, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Synexus Clinical Research US, Inc - Orlando
Orlando, Florida, 32806, United States
Synexus Clinical Research US, Inc.
Pinellas Park, Florida, 33781, United States
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602, United States
Northwestern University
Chicago, Illinois, 60611, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Synexus - Cincinnati
Cincinnati, Ohio, 45236, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
FutureSearch Trials
Austin, Texas, 78731, United States
Synexus - US
San Antonio, Texas, 78229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Related Links
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2021
First Posted
October 20, 2021
Study Start
October 25, 2021
Primary Completion
June 17, 2022
Study Completion
June 17, 2022
Last Updated
October 5, 2023
Results First Posted
October 5, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.