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

Description

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.

Conditions

Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Birmingham

Simon Williamson Clinic, Birmingham, Alabama, United States, 35211

Glendale

Synexus Clinical Research - Glendale, Glendale, Arizona, United States, 85306

Phoenix

Central Phoenix Medical Clinic, Phoenix, Arizona, United States, 85020

Phoenix

Arizona Research Center, Phoenix, Arizona, United States, 85053

Tempe

Alliance for Multispecialty Research, LLC, Tempe, Arizona, United States, 85281

Irvine

Irvine Clinical Research, Irvine, California, United States, 92614

Palm Springs

Desert Oasis Healthcare Medical Group, Palm Springs, California, United States, 92262

Riverside

Artemis Institute for Clinical Research, Riverside, California, United States, 92503

San Diego

Artemis Institute for Clinical Research, San Diego, California, United States, 92103

Hamden

CMR of Greater New Haven, LLC, Hamden, Connecticut, United States, 06517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-04-25