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Recruiting Phase 2 NCT05986292

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

Trial Parameters

Condition Osteoarthritis, Knee
Sponsor Eli Lilly and Company
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 10,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-01-30
Completion 2027-04
Interventions
LY3016859 ISALY3556050 ISALY3526318 ISA

Brief Summary

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.

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, a

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