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

RecruitingPhase 2Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * have a visual analog scale (VAS) pain value โ‰ฅ40 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 โ‰ค30 on the pain catastrophizing scale * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements 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 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.
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What it tests

  • LY3016859 ISA
  • LY3556050 ISA
  • LY3526318 ISA
  • LY3857210 ISA
  • Placebo Oral
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Where

64 sites
Central Research Associates
Birmingham, United States
Simon Williamson Clinic
Birmingham, United States
Synexus Clinical Research - Glendale
Glendale, United States
Synexus Clinical Research US, Inc.
Phoenix, United States
Arizona Research Center
Phoenix, United States
Alliance for Multispecialty Research, LLC
Tempe, United States
Irvine Clinical Research
Irvine, United States
Desert Oasis Healthcare Medical Group
Palm Springs, United States

โ€ฆand 56 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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