Phase
Condition
Chronic Pain
Treatment
LY3857210
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 ormedical history.
Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
Are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.
Are willing to discontinue all medications taken for chronic pain conditions for theduration of the study.
Have a history of low back pain for at least 3 months located between the 12ththoracic 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 1through 3.
Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less thanor equal to 10 at time of screening.
Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion
Exclusion Criteria:
Have a seizure disorder, history of seizure (other than remote history of childhoodfebrile seizure), or a condition that would place the participant at increased riskof seizure, such as head injury (for example, skull fracture, cerebral contusion,concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasmor hemorrhage.
Have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques).
Have surgery planned during the study for any reason, related or not to the diseasestate under evaluation.
Have, in the judgment of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.
Have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual ofMental 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 tobe 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 2years prior to screening.
Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3months prior to starting the washout period.
Have history of or current compression fracture.
Have had a recent major trauma (within 6 months of baseline).
Are pregnant or breastfeeding.
Have known history of gastric or duodenal ulcers.
Have known history of inflammatory bowel disease (including ulcerative colitis orCrohn's disease).
Study Design
Connect with a study center
Ponce Medical School Foundation Inc.
Ponce, 00716
Puerto RicoSite Not Available
Latin Clinical Trial Center
San Juan, 00909
Puerto RicoSite Not Available
Synexus- Chandler
Chandler, Arizona 85224
United StatesSite Not Available
Arizona Research Center
Phoenix, Arizona 85053
United StatesSite Not Available
Artemis Institute for Clinical Research
Riverside, California 92503
United StatesSite Not Available
Artemis Institute for Clinical Research
San Diego, California 92103
United StatesSite Not Available
CMR of Greater New Haven, LLC
Hamden, Connecticut 06517
United StatesSite Not Available
Accel Research Sites- Clinical Research Unit
DeLand, Florida 32720
United StatesSite Not Available
New Horizon Research Center
Miami, Florida 33165
United StatesSite Not Available
Suncoast Research Group
Miami, Florida 33135
United StatesSite Not Available
University of Miami Don Suffer Clinical Research Building
Miami, Florida 33136
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Synexus - US
Orlando, Florida 32806
United StatesSite Not Available
Synexus Clinical Research US, Inc.
Pinellas Park, Florida 33781
United StatesSite Not Available
North Georgia Clinical Research
Woodstock, Georgia 30189
United StatesSite Not Available
Rocky Mountain Clinical Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesSite Not Available
ActivMed Practices and Research
Methuen, Massachusetts 01844
United StatesSite Not Available
MedVadis Research Corporation
Waltham, Massachusetts 02451
United StatesSite Not Available
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
United StatesSite Not Available
StudyMetrix Research
Saint Peters, Missouri 63303
United StatesSite Not Available
Clinvest Research LLC
Springfield, Missouri 65807
United StatesSite Not Available
Lillestol Research LLC
Fargo, North Dakota 58104
United StatesSite Not Available
META Medical Research Institute
Dayton, Ohio 45432
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
FutureSearch Trials
Austin, Texas 78731
United StatesSite Not Available
Synexus Clinical Research US, Inc.
San Antonio, Texas 78229
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesSite Not Available
Rainier Clinical Research Center
Renton, Washington 98057
United StatesSite Not Available

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