A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LY3016859 ISA
DrugAdministered intravenously (IV)
LY3556050 ISA
DrugAdministered orally
LY3526318 ISA
DrugAdministered orally
LY3857210 ISA
DrugAdministered orally
Placebo Oral
DrugPlacebo administered orally
Placebo
DrugPlacebo administered IV
LY4065967 ISA
DrugAdministered orally
Treatment groups
10,000 Participants
are divided into 15 treatment groups15
Treatment groupsSee each treatment group below.
Group A: LY3016859 Osteoarthritis ISAExperimental treatment 2 interventions
Group B: LY3016859 Diabetic Neuropathic Pain ISAExperimental treatment 2 interventions
Group C: LY3016859 Chronic Back Pain ISAExperimental treatment 2 interventions
Group D: LY3556050 Osteoarthritis ISAExperimental treatment 2 interventions
Group E: LY3556050 Diabetic Neuropathic Pain ISAExperimental treatment 2 interventions
Group F: LY3556050 Chronic Back Pain ISAExperimental treatment 2 interventions
Group G: LY3526318 Osteoarthritis ISAExperimental treatment 2 interventions
Group H: LY3526318 Diabetic Neuropathic Pain ISAExperimental treatment 2 interventions
Group I: LY3526318 Chronic Back Pain ISAExperimental treatment 2 interventions
Group J: LY3857210 Osteoarthritis ISAExperimental treatment 2 interventions
Group K: LY3857210 Diabetic Neuropathic Pain ISAExperimental treatment 2 interventions
Group L: LY3857210 Chronic Back Pain ISAExperimental treatment 2 interventions
Group M: LY4065967 Chronic Low Back Pain ISAExperimental treatment 2 interventions
Group N: LY4065967 Osteoarthritis ISAExperimental treatment 2 interventions
Group O: LY4065967 Diabetic Neuropathic Pain ISAExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Who Were Allocated to Each ISA
Time frame
Baseline, Up to Week 8Sponsors and contacts
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Source ClinicalTrials.gov