A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Eli Lilly and Company
10,000 participants
Jan 30, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria10
- 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.
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Interventions
Administered intravenously (IV)
Administered orally
Administered orally
Administered orally
Placebo administered orally
Placebo administered IV
Locations(63)
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NCT05986292