A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Eli Lilly and Company
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.
Description
The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugLY3016859 ISA
Administered intravenously (IV)
- DrugLY3556050 ISA
Administered orally
- DrugLY3526318 ISA
Administered orally
- DrugLY3857210 ISA
Administered orally
- DrugPlacebo Oral
Placebo administered orally
- DrugPlacebo
Placebo administered IV
Locations (64)
- Central Research AssociatesBirmingham, Alabama
- Simon Williamson ClinicBirmingham, Alabama
- Synexus Clinical Research - GlendaleGlendale, Arizona
- Synexus Clinical Research US, Inc.Phoenix, Arizona
- Arizona Research CenterPhoenix, Arizona
- Alliance for Multispecialty Research, LLCTempe, Arizona