The trial is taking place at:
R

Rochester Clinical Research | Rochester, NY

Veeva-enabled site

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

Lilly logo

Lilly

Status and phase

Enrolling
Phase 2

Conditions

Chronic Low-back Pain
Diabetic Neuropathic Pain
Osteoarthritis, Knee

Treatments

Drug: LY3526318 ISA
Drug: LY3857210 ISA
Drug: Placebo Oral
Drug: LY3556050 ISA
Drug: LY3016859 ISA
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05986292
17511
H0P-MC-CPMP (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10,000 participants in 12 patient groups

LY3016859 Osteoarthritis ISA
Experimental group
Description:
Participants are randomized to receive either active LY3016859 or matching placebo
Treatment:
Drug: Placebo
Drug: LY3016859 ISA
LY3016859 Diabetic Neuropathic Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3016859 or matching placebo
Treatment:
Drug: Placebo
Drug: LY3016859 ISA
LY3016859 Chronic Back Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3016859 or matching placebo
Treatment:
Drug: Placebo
Drug: LY3016859 ISA
LY3556050 Osteoarthritis ISA
Experimental group
Description:
Participants are randomized to receive either active LY3556050 or matching placebo
Treatment:
Drug: LY3556050 ISA
Drug: Placebo Oral
LY3556050 Diabetic Neuropathic Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3556050 or matching placebo
Treatment:
Drug: LY3556050 ISA
Drug: Placebo Oral
LY3556050 Chronic Back Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3556050 or matching placebo
Treatment:
Drug: LY3556050 ISA
Drug: Placebo Oral
LY3526318 Osteoarthritis ISA
Experimental group
Description:
Participants are randomized to receive either active LY3526318 or matching placebo
Treatment:
Drug: Placebo Oral
Drug: LY3526318 ISA
LY3526318 Diabetic Neuropathic Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3526318 or matching placebo
Treatment:
Drug: Placebo Oral
Drug: LY3526318 ISA
LY3526318 Chronic Back Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3526318 or matching placebo
Treatment:
Drug: Placebo Oral
Drug: LY3526318 ISA
LY3857210 Osteoarthritis ISA
Experimental group
Description:
Participants are randomized to receive either active LY3857210 or matching placebo
Treatment:
Drug: Placebo Oral
Drug: LY3857210 ISA
LY3857210 Diabetic Neuropathic Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3857210 or matching placebo
Treatment:
Drug: Placebo Oral
Drug: LY3857210 ISA
LY3857210 Chronic Back Pain ISA
Experimental group
Description:
Participants are randomized to receive either active LY3857210 or matching placebo
Treatment:
Drug: Placebo Oral
Drug: LY3857210 ISA

Trial documents
1

Trial contacts and locations

48

Loading...

Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems