Clinical trial NCT05986292: A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Official title: A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Diabetic Neuropathic Pain
Chronic Low-back Pain
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed 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 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, 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.

Primary outcomes:
measure: Number of Participants Who Were Allocated to Each ISA
timeFrame: Baseline, Up to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Simon Williamson Clinic
state: Alabama
city: Glendale
country: United States
facility: Synexus Clinical Research - Glendale
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: University of Miami Don Suffer Clinical Research Building
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research - St. Petersburg
state: Florida
city: Plantation
country: United States
facility: Martin E. Hale M.D., P.A.
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center - Central Office
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Omaha
country: United States
facility: Synexus Clinical Research US, Inc.
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cincinnati
country: United States
facility: Synexus - Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading,LLC
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Synexus
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Murray
country: United States
facility: SYNEXUS
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: