A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Launched by ELI LILLY AND COMPANY · Aug 1, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to study different treatments for chronic pain, specifically in people suffering from conditions like osteoarthritis, knee pain, diabetic neuropathic pain, and chronic low-back pain. The goal is to compare various pain management strategies to see which ones are most effective. The study will include participants who have been experiencing daily pain for at least 12 weeks and have a certain level of pain intensity. Eligible participants should be between the ages of 65 and 74, have a specific body mass index, and be willing to maintain their current pain-relief therapies without starting any new ones during the trial.

If you decide to join this study, you can expect to stop taking your usual chronic pain medications, except for emergency pain relief, for the duration of the trial. Participants will be closely monitored, and they won’t be able to have certain medical conditions or a history of serious illnesses that could affect their safety during the study. This trial is currently recruiting, so if you or someone you know might be interested, it could be a good opportunity to explore new pain management options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening.
• • have a history of daily pain for at least 12 weeks based on participant report or medical history
• • have a value of ≤30 on the pain catastrophizing scale
• • have a body mass index \<40 kilogram/square meter (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, except rescue medication for the duration of the study
• Exclusion Criteria:
• • have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
• • 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 substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
• • have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
• • have a positive human immunodeficiency virus (HIV) test result at screening
• • have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.