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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 64 sites (Birmingham, Alabama and 63 other locations) |
| Status | Recruiting |
| Started | January 30, 2020 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT05986292 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
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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
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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
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.