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
Qualifiers
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)
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
Treatments tested in this trial
- LY3016859 ISA
- LY3556050 ISA
- LY3526318 ISA
- LY3857210 ISA
- Placebo Oral
- Placebo
Treatment groups
10,000 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov