Clinical trial Recruiting at 36 sites Phase 2 Interventional Ages 18 and up

Comparing different treatments for chronic pain conditions

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

Run by Eli Lilly and Company · NCT05986292 · Data updated 2026-11-12

This study is testing different treatments for chronic pain conditions like osteoarthritis and diabetic neuropathy to see which ones work better than a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10000 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations64 sites (Birmingham, Alabama and 63 other locations)
StatusRecruiting
StartedJanuary 30, 2020
Main results expectedApril 2027
Study endsApril 2027
Registry record updatedNovember 5, 2026
Trial IDNCT05986292 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults experiencing daily chronic pain with a visual analog scale pain value between 40 and 95.

Probably not a fit

Patients with severe heart conditions or those who have undergone certain procedures that affect sensory loss in the target area may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate various independent interventions for chronic pain, including osteoarthritis, chronic low back pain, and diabetic neuropathic pain. It utilizes a master protocol that allows for the inclusion of multiple intervention-specific appendices (ISAs) as new treatments become available. Participants will be assessed based on specific entry criteria and unique scales tailored to their pain conditions. The study will compare the effectiveness of these interventions against a placebo to determine their efficacy in managing chronic pain.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from chronic pain.

How similar studies have gone: Other studies have shown promise in evaluating independent interventions for chronic pain, suggesting that this approach could yield valuable insights.

Who can join: the full rules

Show full inclusion / exclusion 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
* are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements 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 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.

Where it's running

  • Central Research Associates
    Birmingham, Alabama, United States
    Recruiting
  • Synexus Clinical Research US, Inc.
    Phoenix, Arizona, United States
    Recruiting
  • Arizona Research Center
    Phoenix, Arizona, United States
    Recruiting
  • Desert Oasis Healthcare Medical Group
    Palm Springs, California, United States
    Recruiting
  • Artemis Institute for Clinical Research
    Riverside, California, United States
    Recruiting
  • Artemis Institute for Clinical Research
    San Diego, California, United States
    Recruiting
Show 44 more locations
  • CMR of Greater New Haven, LLC
    Hamden, Connecticut, United States
    Recruiting
  • Bradenton Research Center, Inc.
    Bradenton, Florida, United States
    Recruiting
  • Accel Research Sites - DeLand Clinical Research Unit
    DeLand, Florida, United States
    Recruiting
  • K2 MEDICAL Research THE VILLAGES
    Lady Lake, Florida, United States
    Recruiting
  • K2 Medical Research ORLANDO
    Maitland, Florida, United States
    Recruiting
  • Merritt Island Medical Research, LLC
    Merritt Island, Florida, United States
    Recruiting
  • Flourish Research - Miami, LLC
    Miami, Florida, United States
    Recruiting
  • New Horizon Research Center
    Miami, Florida, United States
    Recruiting
  • Suncoast Clinical Research, Inc.
    New Port Richey, Florida, United States
    Recruiting
  • Renstar Medical Research
    Ocala, Florida, United States
    Recruiting
  • Precision Clinical Research
    Sunrise, Florida, United States
    Recruiting
  • Charter Research - Lady Lake
    The Villages, Florida, United States
    Recruiting
  • Conquest Research
    Winter Park, Florida, United States
    Recruiting
  • North Georgia Clinical Research
    Woodstock, Georgia, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • DelRicht Research
    New Orleans, Louisiana, United States
    Recruiting
  • Lucida Clinical Trials
    New Bedford, Massachusetts, United States
    Recruiting
  • MedVadis Research Corporation
    Waltham, Massachusetts, United States
    Recruiting
  • Great Lakes Research Group, Inc.
    Bay City, Michigan, United States
    Recruiting
  • StudyMetrix Research
    City of Saint Peters, Missouri, United States
    Recruiting
  • Clinvest Research LLC
    Springfield, Missouri, United States
    Recruiting
  • Rochester Clinical Research, LLC
    Rochester, New York, United States
    Recruiting
  • Lillestol Research
    Fargo, North Dakota, United States
    Recruiting
  • META Medical Research Institute
    Dayton, Ohio, United States
    Recruiting
  • DelRicht Research
    Tulsa, Oklahoma, United States
    Recruiting
  • Altoona Center For Clinical Research
    Duncansville, Pennsylvania, United States
    Recruiting
  • FutureSearch Trials of Neurology
    Austin, Texas, United States
    Recruiting
  • Northwest Clinical Research Center
    Bellevue, Washington, United States
    Recruiting
  • Rainier Clinical Research Center
    Renton, Washington, United States
    Recruiting
  • Ponce Medical School Foundation Inc.
    Ponce, Puerto Rico
    Recruiting
  • Simon Williamson Clinic
    Birmingham, Alabama, United States
    Completed
  • Synexus Clinical Research - Glendale
    Glendale, Arizona, United States
    Completed
  • Alliance for Multispecialty Research, LLC
    Tempe, Arizona, United States
    Completed
  • Irvine Clinical Research
    Irvine, California, United States
    Completed
  • VIN-Julie Schwartzbard
    Aventura, Florida, United States
    Completed
  • Clinical Research of South Florida
    Coral Gables, Florida, United States
    Not yet recruiting
  • University of Miami Don Suffer Clinical Research Building
    Miami, Florida, United States
    Not yet recruiting
  • Synexus Clinical Research US, Inc.
    Orlando, Florida, United States
    Not yet recruiting
  • Synexus Clinical Research - St. Petersburg
    Pinellas Park, Florida, United States
    Completed
  • Martin E. Hale M.D., P.A.
    Plantation, Florida, United States
    Completed
  • Synexus Clinical Research US, Inc.
    The Villages, Florida, United States
    Completed
  • Rocky Mountain Clinical Research
    Idaho Falls, Idaho, United States
    Not yet recruiting
  • Synexus Clinical Research
    Chicago, Illinois, United States
    Completed
  • Cotton O'Neil Clinical Research Center - Central Office
    Topeka, Kansas, United States
    Completed

+14 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.