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Comparing different treatments for chronic pain conditions

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

Phase 2 Interventional Eli Lilly and Company · NCT05986292

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
Enrollment10000 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations64 sites (Birmingham, Alabama and 63 other locations)
Trial IDNCT05986292 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

Eligibility criteria

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
* 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.

Where this trial is running

Birmingham, Alabama and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Osteoarthritis, KneeDiabetic Neuropathic PainChronic Low-back Pain
Last reviewed 2026-06-13 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.