A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Osteoarthritis, Knee Clinical Trial

— CPMP  

Official title:

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986292
• Other study ID #: 17511
• Secondary ID: H0P-MC-CPMP
• Status: Recruiting
• Phase: Phase 2
• Start date: January 30, 2020
• Est. completion date: April 25, 2027

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: April 25, 2027
• Est. primary completion date: April 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Chronic Pain
• Diabetic Neuropathic Pain
• Low Back Pain
• Neuralgia
• Osteoarthritis, Knee

Intervention

Drug:
• LY3016859 ISA
Administered intravenously (IV)
• LY3556050 ISA
Administered orally
• LY3526318 ISA
Administered orally
• LY3857210 ISA
Administered orally
• Placebo Oral
Placebo administered orally
• Placebo
Placebo administered IV

Locations

Country	Name	City	State
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	Latin Clinical Trial Center	San Juan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	VIN-Julie Schwartzbard	Aventura	Florida
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Simon Williamson Clinic	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	Synexus Clinical Research	Chicago	Illinois
United States	Synexus - Cincinnati	Cincinnati	Ohio
United States	Aventiv Research Inc	Columbus	Ohio
United States	Cedar Health Research	Dallas	Texas
United States	Synexus	Dallas	Texas
United States	META Medical Research Institute	Dayton	Ohio
United States	Accel Research Sites- Clinical Research Unit	DeLand	Florida
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Lillestol Research	Fargo	North Dakota
United States	Synexus Clinical Research - Glendale	Glendale	Arizona
United States	PharmQuest	Greensboro	North Carolina
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Irvine Clinical Research	Irvine	California
United States	Encore Research Group- Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	SYNEXUS	Murray	Utah
United States	DelRicht Research	New Orleans	Louisiana
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Renstar Medical Research	Ocala	Florida
United States	Synexus Clinical Research US, Inc.	Omaha	Nebraska
United States	Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Synexus Clinical Research - St. Petersburg	Pinellas Park	Florida
United States	Martin E. Hale M.D., P.A.	Plantation	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Clinvest Research LLC	Springfield	Missouri
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	Synexus Clinical Research US, Inc.	The Villages	Florida
United States	Cotton O'Neil Clinical Research Center - Central Office	Topeka	Kansas
United States	DelRicht Research	Tulsa	Oklahoma
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	Clinical Research Center of Reading,LLC	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Were Allocated to Each ISA		Baseline, Up to Week 8